Trials[JOURNAL]
Sun
200 papers
Controlled local air-balloon compression chest belt on postoperative seroma in breast cancer: study protocol for a randomised controlled trial in Zunyi, China.
Yang Y, Yang L, Zhang N … +2 more , Kang L, Zhang Y
Trials · 2026 Jun · PMID 42343403 · Full text
BACKGROUND: Seroma formation is a common postoperative complication of breast cancer surgery, leading to delayed wound healing, infection, patient discomfort, and repeated outpatient visits. In severe cases, it can cause...
BACKGROUND: Seroma formation is a common postoperative complication of breast cancer surgery, leading to delayed wound healing, infection, patient discomfort, and repeated outpatient visits. In severe cases, it can cause skin flap necrosis, imposing physical, psychological, and financial burdens on patients. Applying compression bandaging to the patient's postoperative wound with a chest strap is an effective measure to prevent seroma formation. However, the commonly used elastic chest straps cannot provide specific compression values, limiting their use. Therefore, we aim to compare the efficacy of standard elastic chest straps versus controlled localised air-balloon compression chest straps in preventing seroma formation following breast cancer surgery. METHODS: This is a superiority, single-blind randomised controlled trial conducted at a tertiary hospital in Guizhou Province, China, involving female breast cancer patients undergoing mastectomy. Eligible participants will be recruited by attending surgeons during routine preoperative consultations. Patients aged 18 years or older diagnosed with unilateral breast cancer who meet the criteria for mastectomy (including modified radical mastectomy and/or simple mastectomy) and provide informed consent will be eligible for inclusion. Exclusion criteria include patients with severe concomitant diseases before surgery, those with chest deformities or trauma, those with chest strap allergies, and those with psychiatric disorders who are unable to cooperate. Sixty patients were randomly assigned to two groups (control group and intervention group) in a 1:1 ratio, without stratification. Patients in the control group received postoperative compression bandaging with standard elastic chest bandages. In contrast, those in the intervention group received postoperative compression bandaging with a controlled-pressure local air-balloon chest bandage, with pressure sensors measuring the air-balloon inflation level. The air-balloon inflation period lasted one week, with inflation values ranging from 4 to 8 kPa. Both sets of chest straps were worn for one month. Safety measures to be collected include adverse events, postoperative complications (seroma, wound infection), and device-related skin reactions or discomfort. Primary outcomes included seroma incidence, postoperative drainage volume, and drainage tube retention time. Secondary outcomes encompassed quality of life, comfort, and satisfaction with the chest straps. DISCUSSION: Postoperative wound compression dressing is essential for promoting flap-to-chest wall adhesion, reducing cavities, preventing seroma formation, and facilitating wound healing. By applying the Controlled Local Air-Balloon Compression Chest Belt, we aim to reduce postoperative complications, improve postoperative comfort, and promote patient recovery. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR), ChiCTR 2500105194. Date of first planned enrolment: February 2025. June 30, 2025 (Clinical Trial Registration Date, retrospectively registered). https://www.chictr.org.cn/showproj.html?proj=277304.
Effect of early dexamethasone on major complications and all-cause mortality in severe burns (DEXA-BURN): study protocol for a multicenter, randomized, placebo-controlled, double-blind trial.
Bourdiol A, Bruder N, Dépret F … +16 more , Flattres D, Flet L, Fortin J, Gaufichon AE, Glavnik B, Jeanne M, Jobert A, Jung B, Lukaszewicz AC, Mathelier N, Péré M, Pichon X, Ravaux H, Mahé PJ, Asehnoune K, DEXA-BURN study group
Trials · 2026 Jun · PMID 42337788 · Full text
BACKGROUND: Severe burns lead to intense and prolonged systemic inflammation and high rates of organ failure and major complications such as acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) and morta...
BACKGROUND: Severe burns lead to intense and prolonged systemic inflammation and high rates of organ failure and major complications such as acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) and mortality. Although corticosteroids have shown benefits in various critical care settings, no adequately powered randomized controlled trial has yet evaluated their effect in burn patients. OBJECTIVES: The DEXA-BURN trial aims to assess whether early administration of dexamethasone reduces the incidence of major complications (moderate-to-severe ARDS or stage 2-3 AKI) and all-cause mortality in adults with severe burns. METHODS: DEXA-BURN is a multicenter, randomized, placebo-controlled, double-blind trial conducted in 10 French intensive care units. Adult patients with ≥ 20% total body surface area (TBSA) burns, admitted within 24 h of injury and requiring mechanical ventilation, will be randomized (1:1) to receive either dexamethasone (0.2 mg/kg/day IV for 5 days) or placebo. Two endpoints are pre-specified and evaluated using a hierarchical testing strategy: (1) major complications within 28 days (moderate-to-severe ARDS or AKI KDIGO stages ≥ 2); and, if statistically significant, (2) all-cause mortality at day 90. Secondary endpoints include nosocomial infections, ventilator-free days, intensive care unit /hospital stay, CRP trajectory, and steroid-related adverse events. A total of 478 patients will be enrolled. Analyses will follow the intention-to-treat and modified intention-to-treat principle. DISCUSSION: This trial will provide high-quality evidence on the effectiveness and safety of corticosteroid therapy in the acute management of severely burned patients. Findings may inform future guidelines and improve critical care practices for this understudied population with a high risk of mortality. TRIAL REGISTRATION: EudraCT: 2024-517708-12-00; ClinicalTrials.gov: NCT06968559. Registered on April 22, 2025.
Impact and implementation evaluation of Stress First Aid for the Substance Use Outreach Workforce (SFA/SUOW): protocol of a hybrid type I cluster randomized control trial.
Desai A, McCormick KA, Rau J … +7 more , Rochani H, Chang P, Westphal RJ, Watson PJ, Claborn KR, Benzer JK, Creech SK
Trials · 2026 Jun · PMID 42323672 · Full text
BACKGROUND: Stress First Aid (SFA), an evidence-informed peer support intervention to address occupational stress, has been adapted to the needs of the substance use outreach workforce (SUOW) (SFA/SUOW) and pilot tested...
BACKGROUND: Stress First Aid (SFA), an evidence-informed peer support intervention to address occupational stress, has been adapted to the needs of the substance use outreach workforce (SUOW) (SFA/SUOW) and pilot tested with initial positive outcomes. The goal of this study is to test and evaluate the effectiveness, implementation and sustainability of SFA/SUOW compared to a no treatment control condition in a hybrid-type I cluster-randomized controlled trial (RCT). METHODS: Approximately 500 substance use outreach workers (SUOWs) and leaders from approximately 90 substance use outreach (SUO) organizations, Community Health Worker programs, and peer support programs arranged in 10 regions based on geographic co-location across Texas, Louisiana, Arkansas, Oklahoma, New Mexico, and tribal areas will be 50:50 randomized to the intervention group or the control group. Treatment will consist of a 2-hour virtual SFA training and up to six virtual 30-minute monthly learning collaboratives. All participants will be asked to complete a baseline assessment prior to randomization, and 2 follow-up assessments at 2-month and 6-month to assess occupational stress primary outcomes: 1) supervisor and coworker social support and 2) burnout. We will also assess use of SFA, job-related affective well-being, secondary traumatic stress, use of coping strategies, general self-efficacy, work engagement, turnover intention, and moral injury symptoms. Additionally, we will conduct interviews and focus groups with RCT participants, RCT non-participants, and addiction professional staff to evaluate the reach, effectiveness, adoption, implementation, and maintenance of SFA/SUOW. DISCUSSION: This RCT provides a robust trial of SFA/SUOW that has not been done before. The aim of the study will result in a national implementation plan to improve SUOWs well-being and subsequently improve quality care for persons who use drugs. TRIAL REGISTRATION: The study NCT07177014 is registered on clinicaltrials.gov https://clinicaltrials.gov/study/NCT07177014. Registered on September 09, 2025.
Long-term evaluation of a comprehensive bullying prevention program starting in preschool: study protocol for a randomized controlled trial.
Dewandre A, Courbet O, Daviot Q … +5 more , Gurgand M, Huillery E, Shankland R, Habib M, Villemonteix T
Trials · 2026 Jun · PMID 42321931 · Full text
BACKGROUND: Promoting mental health and psychological well-being from early childhood is a growing priority in global education policy. Bullying has emerged as a major threat to children's well-being, and while most scho...
BACKGROUND: Promoting mental health and psychological well-being from early childhood is a growing priority in global education policy. Bullying has emerged as a major threat to children's well-being, and while most school-based interventions begin in late childhood or adolescence, research suggests that bullying-related behaviors and peer exclusion emerge as early as preschool. Yet, to date, no bullying prevention program has been rigorously evaluated from the beginning of schooling. This study aims to fill this gap by evaluating Vivre Ensemble-Fri for Mobberi (VE-FFM), a comprehensive, developmentally tailored bullying prevention and social-emotional learning (SEL) program implemented in French primary schools from preschool through elementary school. METHODS: We will conduct a two-arm cluster-randomized controlled trial involving 210 French public schools and approximately 5250 children, recruited at age 3 and followed for 7 years. Schools will be randomly allocated to either the intervention group (VE-FFM) or a wait-list control group continuing with teaching-as-usual. VE-FFM is a universal, whole-school program targeting students, professionals, and families. It focuses on building inclusive peer communities and strengthening children's social-emotional skills through structured group discussions, well-being activities, and SEL workshops. Primary outcomes include bullying and peer victimization. Secondary outcomes include psychological well-being, mental health difficulties, empathy, social skills, academic performance, teacher-child relationship quality, school belonging, subjective unsafety, perception of school kindness, and teacher job satisfaction. Data will be collected at six timepoints using teacher- and child-rated measures. Implementation fidelity will be monitored through teacher logs and recorded classroom sessions. DISCUSSION: This trial is the first to evaluate the long-term impact of a bullying prevention and SEL program beginning at preschool level. By embedding the intervention into the full span of early schooling, VE-FFM may produce stronger and more lasting effects than shorter-term interventions implemented at later stages. Results will inform educational and mental health policy by providing evidence on the effectiveness of early, community-based approaches to preventing bullying and promoting mental well-being. TRIAL REGISTRATION: DRKS; DRKS00037553. Registered on 2025/09/11.
CHIP-AML22: a complex clinical trial in de novo pediatric AML patients, including a gemtuzumab ozogamicin randomization and targeted therapy with quizartinib in eligible subgroups, within the NOPHO-DB-SHIP consortium.
Kaspers GJL, van Hamel M, Abrahamsson J … +27 more , Arad-Cohen N, Benedictus R, Scheidegger N, Castillo L, Ka Leung Cheuk D, Costa V, Duong Y, Fernandez Navarro JM, Fogelstrand L, Goemans BF, Ishimaru S, Jonsson OG, Juul-Dam KL, Karu M, Koedijk JB, Kovalova Z, De Moerloose B, Munthe-Kaas MC, Palmu S, Pasauliene R, Tierens A, van Tinteren H, Turkiewicz D, Valerio DG, Wijnen N, Zwaan CM, Pronk CJ
Trials · 2026 Jun · PMID 42321916 · Full text
BACKGROUND: The overall survival of children with newly diagnosed acute myeloid leukemia (AML) in high-income countries has increased to 80% over the past decades. Nevertheless, a significant subset of patients experienc...
BACKGROUND: The overall survival of children with newly diagnosed acute myeloid leukemia (AML) in high-income countries has increased to 80% over the past decades. Nevertheless, a significant subset of patients experiences relapse and treatment is associated with both short- and long-term toxicities. The CHIP-AML22 protocol includes an updated standard-of-care treatment for children with AML within the NOPHO-DB-SHIP consortium. Targeted therapies are offered to specific subsets of patients and measures to reduce toxicity are being investigated. METHODS: CHIP-AML22 is a multinational complex clinical trial in newly diagnosed de novo AML patients up to and including 18 years of age, sponsored by the Princess Máxima Center. The primary aim is to improve event-free survival. To achieve this, (1) FLT3-ITD+/NPM1wt patients can participate in a linked-trial assessing safety and efficacy of quizartinib, in addition to conventional chemotherapy during induction and consolidation therapy and as continuation monotherapy after allogeneic hematopoietic stem cell transplantation; (2) a randomization study is incorporated on the use of two doses of 3 mg/m gemtuzumab ozogamicin during induction therapy in CD33-positive patients; and (3) updated criteria are used for the identification of high-risk patients, based both on flow measurable residual disease (MRD) and (cyto)genetic profiling. The design allows for introduction of new treatment options in the future. Furthermore, a randomization is included aiming to demonstrate non-inferiority in disease-free survival after two versus three consolidation courses in standard-risk patients. Additionally, the use of the cardioprotective drug dexrazoxane is recommended in all patients. Interim analyses will be conducted to assess safety and efficacy in the linked trial and randomization studies. Based on power calculations, we aim to recruit a total of 905 patients in the Master protocol and 60 patients in the linked Quizartinib trial. DISCUSSION: The risk-based approach and use of targeted therapies in CHIP-AML22 illustrate a shift toward more personalized treatment. Besides improving event-free survival, this study aims to contribute to the international consensus on strategies to reduce toxicity for all patients. The design of this study provides a dynamic framework, allowing for the potential introduction of emerging therapeutic options in the future. TRIAL REGISTRATION: CHIP-AML22 Master protocol: EU CT 2023-504999-25-00, Clinicaltrials.gov NCT05994690. Registered on 16-08-2023 Quizartinib linked-trial: EU CT 2023-505000-27-01, Clinicaltrials.gov NCT06262438. Registered on 16-02-2024.
Integrative Music Therapy for Depression-related Disorders (iMTDep) - study protocol for a randomised controlled trial.
Ala-Ruona E, Raittila TL, Taipale M … +6 more , Natarajan N, Hartmann M, Mavrolampados A, Ansani A, Löyttyniemi E, Erkkilä J
Trials · 2026 Jun · PMID 42321902 · Full text
BACKGROUND: Depression, anxiety and work-related stress affect a significant number of adults disrupting their productivity, ability to function and attend work. These highly comorbid disorders tend to be difficult to tr...
BACKGROUND: Depression, anxiety and work-related stress affect a significant number of adults disrupting their productivity, ability to function and attend work. These highly comorbid disorders tend to be difficult to treat effectively, and more information about integrative treatment approaches is needed. This study investigates the effectiveness of music therapy in treating depression-related disorders. METHODS/DESIGN: The intervention is targeted at people of 18-65 years of age who are in employment, in their studies, temporarily unemployed, on short-term sick leave or rehabilitation allowance and suffer from depression-related disorders, which include one or several of the following: depression, anxiety, work-related stress or exhaustion. The interventions applied are Integrative Improvisational Music Therapy (IIMT) with or without the additional elements of music listening and vibroacoustic treatment. All sessions will begin with a preparative exercise called Resonance Frequency Breathing to enhance the effect of the therapy. All participants will receive the intervention for 6 weeks (60-min therapy session twice a week). The participants will be randomised into four groups that will have different modifications of the intervention, and the group without additional elements will serve as a waiting-list control group. The primary outcome will measure psychological distress. Secondary outcomes will address depression, anxiety, exhaustion, burnout, health-related quality of life and challenges in recognising emotions (alexithymia). DISCUSSION: The trial will elevate our understanding of the efficacy of integrative improvisational music therapy for depression-related disorders. Results will give more information about the combinations of additional elements used as part of the intervention. Extensive dataset will allow us to investigate the dynamics of therapeutic change and the factors that predict certain responsiveness to the intervention or explain the effects. TRIAL REGISTRATION: Prospectively registered on ISRCTN on 12.04.2024 (ISRCTN26812986). Study was approved by the Regional Medical Research Ethics Committee of Wellbeing Services County of Central Finland 15.02.2024 (ref: 7U/2023).
Effectiveness of abdominal hollowing and piriformis stretching exercises in spondylolisthesis patients: a study protocol for a randomized controlled trial.
Dey G, Hossain MA, Halder P … +3 more , Huda MN, Adhikari M, Alam F
Trials · 2026 Jun · PMID 42321860 · Full text
BACKGROUND: Lumbar spondylolisthesis is a clinically important cause of chronic low back pain, activity limitation, and reduced functional capacity. Exercise-based physiotherapy is widely recommended for conservative man...
BACKGROUND: Lumbar spondylolisthesis is a clinically important cause of chronic low back pain, activity limitation, and reduced functional capacity. Exercise-based physiotherapy is widely recommended for conservative management, yet uncertainty remains regarding the added value of targeted core stabilization and hip-related stretching strategies in this population. Abdominal hollowing is intended to improve deep trunk muscle activation and lumbopelvic control, whereas piriformis stretching may reduce posterior hip tightness and movement-related discomfort. This trial aims to evaluate whether adding abdominal hollowing and piriformis stretching exercises to a standardized conventional physiotherapy programme improves pain, functional disability, and kinesiophobia in adults with low-grade lumbar spondylolisthesis. METHODS: This study is a two-arm, parallel group, assessor-blinded randomized controlled superiority trial. Seventy-two participants aged 18 to 65 years with radiologically confirmed lumbar spondylolisthesis of Meyerding grade I or II, chronic localized low back pain of more than 3 months, and a baseline pain intensity of more than 3 on a 10-point Visual Analogue Scale will be recruited from the Musculoskeletal Physiotherapy Unit of the Centre for the Rehabilitation of the Paralysed, Savar, Bangladesh. Recruitment is planned from April 2026 to June 2026. Participants will be allocated in a 1:1 ratio using a computer-generated block randomization sequence with concealed allocation. Both groups will receive a standardized conventional physiotherapy programme three times weekly for 6 weeks. The experimental group will additionally receive abdominal hollowing and piriformis stretching exercises. The primary outcome will be pain intensity measured by the 10-cm Visual Analogue Scale immediately after the 6-week intervention. Secondary outcomes will include functional disability measured by the Oswestry Disability Index, kinesiophobia measured by the Tampa Scale for Kinesiophobia, and all outcome measures assessed at 4-week follow-up. Data will be analysed according to the intention-to-treat principle using linear mixed effects models, with effect estimates reported alongside 95% confidence intervals. DISCUSSION: This trial will determine whether adding targeted core stabilization and piriformis stretching to a standardized physiotherapy programme produces superior short-term clinical outcomes in people with lumbar spondylolisthesis. The findings may inform conservative rehabilitation strategies for this population, particularly in resource-limited clinical settings. TRIAL REGISTRATION: Clinical Trial Registry India (CTRI), CTRI/2025/07/089927. Registered prospectively on 01 July 2025.
Effectiveness of adapted physical activity and therapeutic exercise programme in improving chronic fatigue syndrome in long COVID, delivered via hospital-based rehabilitation versus telerehabilitation.
Kabir F, Yin KN, Jeffree MS … +8 more , Ahmedy FB, Jahan S, Rahman E, Galeb AH, Ahmed S, Hossain T, Ahmed R, Hossain MA
Trials · 2026 Jun · PMID 42310705 · Full text
BACKGROUND: Long COVID is a prevalent condition characterised by pain, fatigue, disability, and a multitude of health issues. There are various treatment options for managing long COVID symptoms, including non-pharmacolo...
BACKGROUND: Long COVID is a prevalent condition characterised by pain, fatigue, disability, and a multitude of health issues. There are various treatment options for managing long COVID symptoms, including non-pharmacological interventions like physiotherapy and rehabilitation, which can be effectively delivered either in institutional care settings or via telerehabilitation. METHODS: This three-arm randomised controlled trial included 145 participants selected from a population-based cohort in eight administrative divisions in Bangladesh. Participants aged 18 and above diagnosed with chronic fatigue syndrome (CFS) secondary to long COVID were included and history of fatigue, cardiovascular, neuro-musculoskeletal, or respiratory diseases, or red flag signs were excluded. Participants were allocated to three groups: hospital-based rehabilitation (HBR), telerehabilitation (TR), or a home programme (HP). Interventions consisted of an individualised exercise programme. The HBR and TR groups received physiotherapist-supervised sessions with sessions lasting 45 min, twice weekly for 8 weeks. And the HP group performed exercises independently following structured instruction. Fatigue, the primary outcome, was measured using the Chalder fatigue scale, while secondary outcomes were quality of life measured using the 36-item Short Form Survey (SF-36), disability-adjusted life years (DALYs), and cardiorespiratory parameters (blood pressure, pulse rate, oxygen saturation, and lung capacity). FINDING: Between 1st July 2023 and 31st December 2023, 145 participants were enrolled, with a mean age of 46.1 ± 6.7 years. After 8 weeks of intervention, the among-group within-group comparison showed a significant difference in fatigue level (HBR: P < 0.001; TR: P < 0.001; HP: P < 0.321), physical functioning (HBR: P < 0.001; TR: P < 0.001; HP: P < 0.057), and episodic disability (HBR; TR; HP: P < 0.001) among the participants when comparing them between the groups. In multiple comparisons, results showed that differences were observed in the Chalder fatigue scale, physical functioning, and episodic disability between all groups. Hospital-based rehabilitation showed a lower mean score compared to telerehabilitation (p < 0.0001) and the home programme (p < 0.0001). Additionally, telerehabilitation was significantly better than the home programme (p < 0.0001), indicating hospital-based rehabilitation's superior efficacy in reducing fatigue, improving physical function, and reducing disability. CONCLUSION: Physiotherapy as hands-on implementation in a hospital setting was substantially more effective than telerehabilitation. Training healthcare professionals to improve accessibility to rehabilitation would help mitigate the consequences of long COVID-19. TRAIL REGISTRATION: The trial was registered with the clinical trial registry of India (CTRI/2023/03/050808. Registered on 17/03/2023).
In-office balloon dilation for baro-challenge-induced Eustachian tube dysfunction: study protocol for a randomized sham-controlled trial.
Aleinati M, Spiegel JL, Le TN … +1 more , Lui JT
Trials · 2026 Jun · PMID 42310698 · Full text
BACKGROUND: Balloon dilation of the Eustachian tube (BDET) is a potential treatment for Eustachian tube dysfunction (ETD). However, high-quality evidence for its efficacy in baro-challenge-induced ETD (BCETD) is lacking....
BACKGROUND: Balloon dilation of the Eustachian tube (BDET) is a potential treatment for Eustachian tube dysfunction (ETD). However, high-quality evidence for its efficacy in baro-challenge-induced ETD (BCETD) is lacking. Blinded, sham-controlled trials are critical in this context, particularly given the largely subjective nature of this condition. The objective of this study protocol is to test the hypothesis that BDET is superior to a sham procedure in reducing symptoms of BCETD. METHODS: This randomized, sham-controlled, multicenter trial will be conducted at multiple tertiary care centers in Canada. Adults experiencing BCETD symptoms and have failed conservative management will be randomized to undergo BDET or a sham procedure. The BDET group will undergo in-office balloon dilation under local anesthesia, while the sham group will undergo an in-office sham procedure. The primary outcome measure is the change in BCETD symptom severity as measured by the 7-item baro-challenge-induced Eustachian tube dysfunction questionnaire (BCETDQ-7), an adapted version of the 7-Item Eustachian tube dysfunction questionnaire (ETDQ-7), at 6 weeks post-procedure. Secondary outcomes include the ETDQ-7, ability to perform a middle ear pressure equalization maneuver, health-related quality of life (EQ-5D-5L questionnaire), and subjective work and activity impairment. Outcome measures will be assessed at baseline and at 6-, 24-, and 52-weeks post-procedure. DISCUSSION: BDET may offer a minimally invasive therapeutic option for BCETD patients who fail medical management, but the lack of blinded and sham-controlled studies limits the reliability of patient-reported outcomes. This trial will offer the first blinded and sham-controlled study of BDET in the BCETD population. This design aims to reduce bias and improve the reliability of patient-reported outcomes. Upon study completion and data analysis, we intend to publish our findings in a peer-reviewed journal. If BDET is found to be effective, it may offer a novel, minimally invasive treatment option for BCETD, addressing a critical gap in management of this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05719207. Registered on 01/15/2023.
Effectiveness of peer counselling in addressing psychological distress and exposure to violence among sexual and gender minorities in Nepal: a study protocol for a randomized controlled trial.
Deuba K, Shrestha R, Koju R … +5 more , Dhakal M, Underhill J, Binder PE, Sandøy IF, SAATHI study group
Trials · 2026 Jun · PMID 42304403 · Full text
BACKGROUND: The burden of social stressors (discrimination, prejudice, violence, and stigmatization) is disproportionately high among LGBTIQA + (Lesbian, Gay, Bisexual, Transgender, Intersex, Queer and Asexual) individua...
BACKGROUND: The burden of social stressors (discrimination, prejudice, violence, and stigmatization) is disproportionately high among LGBTIQA + (Lesbian, Gay, Bisexual, Transgender, Intersex, Queer and Asexual) individuals. These stressors negatively influence the overall well-being of this population which in turn affects their health-seeking behaviours, including the disclosure of psychosocial concerns to health workers. Peer-led mental health interventions have therefore been identified as a potentially suitable and acceptable approach for this population. This protocol presents the SAATHI (Support, Advocacy, and Awareness for Trauma, Healing and Inclusion) study. The study will assess the feasibility, acceptability, and effectiveness of peer counselling, safety planning, and group-based sessions in reducing exposure to violence and psychological distress among LGBTIQA + individuals in Nepal. METHODS: We will conduct a three-arm randomized controlled trial with a 1:1:1 allocation ratio. At least 1062 LGBTIQA + participants will be enrolled. Eligibility criteria include age 18-55 years, a history of violence in the past 12 months, and a score of ≥ 3 on the General Health Questionnaire, indicating psychological distress. Participants in the intervention arms will receive six 90-min peer-led counselling sessions and one of the arms will receive monthly peer-led group sessions for shared reflection and support. Follow-up assessments will occur at 7 weeks, 18 weeks, and 12 months post-baseline. A qualitative process evaluation will be conducted of the intervention delivery. The primary outcomes are psychological distress and exposure to violence. The secondary outcomes include post-traumatic stress disorder, participant-reported psychological outcomes, daily functioning, self-esteem, self-compassion, perceived social support, use of personal safety strategies, and satisfaction with community resources. We will analyse quantitative data using intention-to-treat principles. For the qualitative data, our approach will be reflexive thematic analysis, which is grounded in a critical realist/contextualist ontology. DISCUSSION: This study ultimately aims to reduce health disparities and improve the health and well-being of LGBTIQA + individuals. If effective, the SAATHI intervention has potential to be sustainable through empowered peer-led networks and scalable in low- and middle-income countries due to its low-cost, community-implemented design. TRIAL REGISTRATION: ClinicalTrials.gov NCT06979193. Registered on 20 May 2025, https://clinicaltrials.gov/study/NCT06979193.
English language ability as an exclusion criterion in emergency research taking place in the East Midlands, its impact on recruitment and a survey of the views of research professionals.
Sherman R, Tabner A, Johnson G
Trials · 2026 Jun · PMID 42298725 · Full text
BACKGROUND: English language ability is commonly used within eligibility criteria in research, despite limited strategies to assess it objectively. Improving inclusion of underserved groups in research is an important an...
BACKGROUND: English language ability is commonly used within eligibility criteria in research, despite limited strategies to assess it objectively. Improving inclusion of underserved groups in research is an important and ongoing priority for the research community, including funding bodies such as the National Institute for Health and Care Research (NIHR). We asked how excluding those who cannot communicate in English impacts recruitment in Trauma and Emergency Care trials taking place in the East Midlands (UK) and explored drivers behind including such eligibility criteria. METHODS: We reviewed Trauma and Emergency Care studies with at least one site in the East Midlands, which completed in the 5 years prior to November 2020 and included English language ability within their eligibility criteria. We obtained screening data where available (numbers screened and excluded, and reasons for exclusion) to estimate exclusions due to language. We conducted an online survey of research professionals based in East Midlands' Research & Development departments, Clinical Trials Units and Research Ethics Committees, to explore views on the use of this criterion. RESULTS: We found that 18% of the 129 studies reviewed directly excluded those unable to communicate in English. Screening data were available for 5/15 studies included in the analysis; 2-7% of screened patients were excluded due to language. Those we surveyed showed an awareness of the ethical and scientific issues raised by this exclusion among respondents and perceived the drivers behind this exclusion to be linked to costs. CONCLUSIONS: A lack of available screening data meant that we were unable to determine the true scale of exclusion based on English language ability in publicly funded emergency medicine research in the East Midlands, but our findings indicate that it may impact on overall recruitment to studies, as exclusion rates were higher than that reported in the population. Given the importance of improving inclusivity and diversity in research, more work is needed to understand this at a national level and determine if strategies to overcome language barriers can support inclusivity and overall recruitment rates.
Design of a mobile application and evaluation of its effects on clinical outcomes in patients with dry eye disease: a study protocol for a randomized controlled trial.
Khodabandeh ME, Farrahi R, Sargolzaei M … +4 more , Mohammadi M, Khodabandeh AHE, Zarei-Ghanavati S, Eslami S
Trials · 2026 Jun · PMID 42298714 · Full text
BACKGROUND: Dry eye is a common ocular surface disorder resulting from tear deficiency or excess tear evaporation. This protocol will be implemented for a study designed to determine the effectiveness of a mobile self-ca...
BACKGROUND: Dry eye is a common ocular surface disorder resulting from tear deficiency or excess tear evaporation. This protocol will be implemented for a study designed to determine the effectiveness of a mobile self-care application on objective clinical test results and subjective symptoms in patients with dry eye disease. METHODS: The first stage will include the development of a mobile self-care application using the Python framework of Flask technology and SQLite database in the backend, and the Flutter framework of Dart for the bot technology in the front end. The second stage will be conducted using a two-arm blinded randomized clinical trial. The sample size calculation initially targeted 104 patients with dry eye disease, intended for division into intervention and control groups via an online random number generator. However, unforeseen challenges, including COVID-19 disruptions, led to randomization of 181 patients (91 intervention, 90 control).This resulted in 104 completers after a 42.5% dropout rate. Patients in both groups will receive usual medical care, but those in the intervention group will also use a mobile-based application for a period of 12 weeks. Study outcomes including the Tear Break-Up Time clinical test as the primary outcome, and the validated Persian version of the Ocular Surface Disease Index questionnaire as a secondary outcome measure in patients with dry eye disease, will be assessed at 6- and 12-weeks post-baseline. DISCUSSION: It is expected that delivering customized training via a mobile application during clinical visits would promote improvement and reduction of disease severity, as well as strengthen the physician-patient relationship. This study was developed by an interdisciplinary research team in accordance with current dry eye disease guidelines and taking into account the medical history and classification of dry eye disease. Considering the lack of financial resources for traditional self-care methods and the development of technologies based on mobile health, it seems that one can hope for the acceptance of such systems in the patients with dry eyes. TRIAL REGISTRATION: This protocol is registered in the Iranian registration of clinical trial (IRCT) with the code IRCT20200721048162N1. Registered 31 August 2020, URL: https://irct.behdasht.gov.ir/trial/49779.
Comparison of endovascular procedures of the lower extremities and iliac arteries with and without navigation assistance Vascular Navigation PAD: study protocol for a prospective multicenter randomized clinical trial.
Masius S, Zerwes S, Gombert A … +2 more , Uhl C, Hyhlik-Dürr A
Trials · 2026 Jun · PMID 42298710 · Full text
BACKGROUND: Endovascular procedures using a mobile C-arm are commonly performed in patients with peripheral artery disease. During these procedures, digital subtraction angiography (DSA) requires intra-arterial administr...
BACKGROUND: Endovascular procedures using a mobile C-arm are commonly performed in patients with peripheral artery disease. During these procedures, digital subtraction angiography (DSA) requires intra-arterial administration of contrast agent and exposes both patients and staff to radiation from the C-arm. The Vascular Navigation PAD system (Brainlab, Germany) may reduce the number of DSAs performed and thereby decrease both contrast agent use and radiation exposure. The objective of this study is to evaluate the safety and clinical performance of the Vascular Navigation PAD system compared with standard care in endovascular PAD treatment. The primary aim is to determine whether the device reduces the volume of contrast agent used during lower-extremity procedures. Secondary objectives include assessing patient and physician radiation exposure, patient air kerma, and the device's ability to support accurate endovascular navigation. METHODS: This is a multicenter, prospective, randomized confirmatory trial comparing navigation-assisted procedures with conventional procedures without navigation assistance. Patients allocated to the intervention group will undergo treatment using Vascular Navigation PAD in addition to a mobile C-arm. A total of 160 patients will be randomized in a 1:1 ratio, with 40 patients per group enrolled at each of the two participating hospitals. The primary endpoint is contrast agent volume. Secondary endpoints include patient radiation exposure, physician radiation exposure, fluoroscopy time, and the number of DSAs performed per intervention. DISCUSSION: This study will evaluate whether the Vascular Navigation PAD system can reduce the number of DSAs in endovascular treatment. A reduction in DSAs may lead to lower contrast agent use and reduced radiation exposure for both patients and staff. TRIAL REGISTRATION: The clinical trial is registered at the German Clinical Trials Register (ID: DRKS00035267). Registered on 10.Jan.2025.
ORIGIN-1 trial: study protocol for an organoid-guided N-of-1 trial evaluating CFTR modulator response in cystic fibrosis with rare non-F508del mutations.
Sabino LR, Kaiko GE, Dorahy D … +11 more , Goodsall T, Jaffe A, Schultz A, Waters S, Cook D, Kok H, Tong K, Totterdell J, McGree J, Snelling T, Wark PAB
Trials · 2026 Jun · PMID 42298697 · Full text
BACKGROUND: Cystic fibrosis (CF) is a genetic condition caused by mutation of the cystic fibrosis transmembrane regulator (CFTR) gene. Recently licensed modulator therapies target the defective CFTR protein and have tran...
BACKGROUND: Cystic fibrosis (CF) is a genetic condition caused by mutation of the cystic fibrosis transmembrane regulator (CFTR) gene. Recently licensed modulator therapies target the defective CFTR protein and have transformed the formerly life-limiting trajectory of people with CF (pwCF). elexacaftor/tezacaftor/ivacaftor (ETI) has shown outstanding clinical efficacy in pwCF homozygous for F508del (approximately 50%), and those with a F508del mutation paired with any of the > 2000 other mutations identified in the CFTR gene (heterozygous pairing). However, clinical response to modulators is variable and people with rare CF mutations are often excluded from modulator access worldwide. The ORIGIN-1 trial aims to determine whether an organoid-guided n-of-1 trial can predict and demonstrate clinical response to ETI in pwCF with rare mutations. METHODS: Based on the in vitro testing, participants will be eligible to enter the interventional phase of the trial. Participants will be administered blinded study drug (i.e. ETI or placebo) for a 14-day treatment block followed by a 14-day washout period prior to beginning the alternate treatment, again for a 14-day period. A treatment cycle will be defined as one ETI treatment block, one placebo treatment block and the intervening washout period. Treatment blocks sequence will be randomly assigned. Participants will complete a minimum of two treatment cycles and up to four consecutive cycles depending on the results of planned interim analyses. DISCUSSION: The ORIGIN-1 trial is designed to demonstrate a precision medicine approach that targets CFTR modulator therapy to ensure the optimal use of these very high-cost therapies. This pathway may expand the application of CFTR modulators to include pwCF with rare mutations of the CFTR gene for whom CFTR modulators' efficacy has not been (and are unlikely to ever be) proven by conventional, parallel-group clinical trials. We anticipate that a personalised organoid model that measures patient-specific CFTR responses to modulators in vitro will enable the reliable identification of pwCF with these rare CFTR mutations who are likely to respond to existing modulator therapy. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR) ID: ACTRN12623001136695 Registered on November 03, 2023.
Effectiveness of sensory electrical stimulation augmented virtual reality training on sitting balance and quality of life in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial.
Chowdhary N, Khanna S, Wadhwa G … +1 more , Walia S
Trials · 2026 Jun · PMID 42298600 · Full text
BACKGROUND: Individuals with incomplete spinal cord injury (iSCI) often face significant impairments in sitting balance and mobility due to trunk instability. These challenges can severely impact functional abilities, pa...
BACKGROUND: Individuals with incomplete spinal cord injury (iSCI) often face significant impairments in sitting balance and mobility due to trunk instability. These challenges can severely impact functional abilities, participation in daily activities, and overall quality of life (QoL). Studies have demonstrated the potential of virtual reality (VR) training to improve sitting balance in individuals with iSCI. Furthermore, sensory electrical stimulation (SES) has shown positive effects on sitting balance in various neurological populations. However, research exploring the combined effectiveness of virtual reality and sensory electrical stimulation on sitting balance and QoL, specifically within the iSCI population, remains limited. METHODOLOGY: This study will be an assessor-blind, parallel, two-group, randomized controlled trial that aims to evaluate the effectiveness of SES-augmented VR-based balance training on sitting balance and QoL in individuals with iSCI. A total of 22 participants with iSCI, with a neurological level of injury between T6 and T12, will be recruited from the rehabilitation department at the Indian Spinal Injuries Centre, adhering to inclusion criteria. Participants will be randomly assigned to one of two groups using a 1:1 allocation ratio. The experimental group will engage in VR-based balance training along with SES application, while the control group will engage solely in VR-based balance training. Both groups will receive interventions consisting of 30-min sessions five times a week for a duration of 4 weeks. OUTCOME MEASURES: The assessment of sitting balance will be done using the modified functional reach test (mFRT) and the star test using the Tecnobody ProKin 252 trunk sensor. Additionally, the International Spinal Cord Society Quality of Life Basic Data Set (ISCoS QoL BDS) version 1.0 will be used to measure QoL. DISCUSSION: The effectiveness of the SES-augmented VR-based balance training will be evaluated based on the changes in the mFRT, star test (ProKin 252 trunk sensor), and ISCoS QoL BDS version 1.0 following 4 weeks of intervention. This trial aims to enhance understanding of how SES-augmented VR training can improve sitting balance and QoL in individuals with iSCI. TRIAL REGISTRATION: The trial is registered with the Clinical Trials Registry-India on 18th April 2024 with registration number CTRI/2024/04/065897.
Glue versus Laser Ablation in Mini-invasive Pilonidal sinus surgery-the GLAMP study: a study protocol for a randomised controlled trial.
Koskinen K, Koppatz H, Poussa T … +2 more , Harju J, Hermunen K
Trials · 2026 Jun · PMID 42288936 · Full text
BACKGROUND: Pilonidal sinus disease (PSD) is a chronic acquired condition leading to significant morbidity and healthcare costs in the working-age population. Randomised studies of PSD surgery are rare, and this applies...
BACKGROUND: Pilonidal sinus disease (PSD) is a chronic acquired condition leading to significant morbidity and healthcare costs in the working-age population. Randomised studies of PSD surgery are rare, and this applies especially to newer mini-invasive techniques. The purpose of our study is to compare two mini-invasive techniques in PSD surgery: laser ablation and fibrin glue treatment. METHODS: This randomised, prospective, multicentre superiority non-blinded study compares two parallel groups of PSD patients treated with laser ablation and fibrin glue. It compares the outcome of these mini-invasive treatment options in regards to both short-term outcome (healing rate) and long-term outcome (recurrence rate), and to the cost of these two treatment options. On the day of surgery, if the operating surgeon indicates that a patient is suitable for laser ablation and glue treatment, that patient is randomly assigned to one of those two surgery groups. After the operation, the operating surgeon completes the examination form. Patients are asked to complete a quality-of-life questionnaire (RAND-36/SF-36) preoperatively and 2 months after surgery. Further, at 2 months, patients also complete an additional questionnaire regarding any discomfort, symptoms, and recovery. All statistical analyses are performed by means of standard statistical software such as SPSS and NCSS. DISCUSSION: In PSD surgery, very few prospective randomised trials exist, which makes it difficult to compare various surgical methods. Earlier prospective randomised studies involving laser and glue include numbers of patients that are also relatively small, which is why comparisons of methods have not achieved statistical significance. Our study aims to compare two minimally invasive techniques to discover their short- and long-term differences regarding recovery and healing. TRIAL REGISTRATION: This trial was retrospectively registered in ClinicalTrials.gov on April 30, 2025 (NCT06964763). https://clinicaltrials.gov/study/NCT06964763?term=hermunen&rank=1.
The Scandinavian Displaced Lateral Clavicle trial (ScanDiLaC): a study protocol for a randomized clinical trial.
Christersson P, Karimi D, Grønhaug K … +6 more , Launonen A, Brorson S, Frihagen F, Viberg B, Hailer N, Wolf O
Trials · 2026 Jun · PMID 42288927 · Full text
BACKGROUND: Evidence regarding the treatment of displaced, extraarticular lateral clavicle fractures is scarce. No study has shown clinically significant differences between surgical and nonsurgical treatment, but the sa...
BACKGROUND: Evidence regarding the treatment of displaced, extraarticular lateral clavicle fractures is scarce. No study has shown clinically significant differences between surgical and nonsurgical treatment, but the sample sizes have been small, as it has been difficult to include enough patients with this relatively uncommon fracture type. PURPOSE: This study aims to compare outcomes after surgical and nonsurgical treatment for displaced lateral clavicle fractures. METHODS: This is a pragmatic, noninferiority, preference-tolerant, randomized controlled trial (RCT). A total of 100 patients between the ages of 18 and 65 with displaced lateral clavicle fractures will be randomly allocated on a 1:1 ratio to surgical or nonsurgical treatment with the option of early crossover after 6 weeks. An observational cohort will comprise patients not willing to be randomized. This is a multicenter Scandinavian RCT including hospitals in Sweden, Norway, Denmark, and Finland. The primary outcome is the Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year. Follow-up points will be 6 weeks, 3 months, 6 months, and 1 year. The secondary outcomes are the DASH score, the EQ-5D-5L score, the University of California, Los Angeles (UCLA) activity score, the Nottingham Clavicle Score (NCS), a visual analog scale (VAS) for pain, and anchor questions in the form of the Patient Global Impression of Change (PGIC) collected at all timepoints during the study. All complications, radiographic healing, and return to work will be reported. DISCUSSION: The optimal treatment for displaced Neer type II and V lateral clavicle fractures remains a topic of debate. This RCT may provide a better understanding of the differences in outcomes of nonsurgical and surgical treatment while reflecting real-world clinical practice and guiding the development of a treatment algorithm for the orthopedic community. TRIAL REGISTRATION: ClinicalTrials.gov NCT06981065. Registered on 19 May 2025. https://clinicaltrials.gov/study/NCT06981065?term=Scandilac&rank=1.
A comparative study of targeted end-tidal carbon dioxide versus standard management to guide resuscitation in emergency department cardiac arrest in Thailand: study protocol for a three-arm randomised controlled trial.
Srivilaithon W, Limjindaporn C, Kornthatchapong K … +9 more , Imsuwan I, Daorattanachai K, Diskumpon N, Dasanadeba I, Siripakarn Y, Ueamsaranworakul T, Pornpanit C, Chatchairatanavej N, Tivirach P
Trials · 2026 Jun · PMID 42286753 · Full text
BACKGROUND: Cardiac arrest managed in the emergency department (ED) is associated with suboptimal survival outcomes. End-tidal carbon dioxide (EtCO) monitoring during cardiopulmonary resuscitation (CPR) reflects cardiac...
BACKGROUND: Cardiac arrest managed in the emergency department (ED) is associated with suboptimal survival outcomes. End-tidal carbon dioxide (EtCO) monitoring during cardiopulmonary resuscitation (CPR) reflects cardiac output, tissue perfusion, and pulmonary blood flow. Observational evidence suggests that higher EtCO levels during CPR are associated with return of spontaneous circulation (ROSC), but the effect of actively targeting higher EtCO thresholds remains uncertain. The primary objective of this trial is to determine whether CPR guided by higher EtCO targets improves sustained ROSC compared with a standard EtCO target among patients with ED cardiac arrest. METHODS: This is a single-centre, three-arm, single-blind, superiority randomised controlled trial conducted in the ED of Thammasat University Hospital, Pathum Thani, Thailand. Eligible participants are patients with ED cardiac arrest, including out-of-hospital cardiac arrest patients receiving CPR in the ED and patients with first in-hospital cardiac arrest occurring in the ED. Exclusion criteria include age < 15 years, traumatic cardiac arrest, a do-not-attempt-resuscitation order, and signs of irreversible death. Post-randomisation exclusions include inability to obtain EtCO monitoring through an advanced airway and ROSC before the first EtCO measurement. Consecutive eligible participants will be screened and enrolled by the attending emergency physician. Participants will be randomised in a 1:1:1 ratio using fixed-block randomisation with a block size of six; no stratification variables will be used. The planned sample size is 300 participants, with 100 participants per group. All participants will receive high-quality CPR according to international resuscitation guidelines and will be assigned to one of three EtCO targets: ≥ 10 mmHg, ≥ 20 mmHg, or ≥ 25% of venous partial pressure of carbon dioxide (PvCO), with a minimum threshold of 10 mmHg. Peripheral venous PvCO will be obtained using point-of-care testing every 10 min. Chest compression depth and rate will be titrated in 0.5-cm and 10/min increments, respectively, every 30 s until the assigned EtCO target is achieved. The primary outcome is sustained ROSC. Secondary outcomes include survival to hospital discharge and survival with favourable neurological outcome. Safety and harm measures include adverse events related to the study intervention, unanticipated device-related issues, and complications attributed to study-directed chest-compression adjustments. These events will be documented, reported to the coordinating centre and ethics committee as required, and reviewed by the Data Safety Monitoring Board. Analyses will follow both intention-to-treat and per-protocol principles. DISCUSSION: This trial will evaluate whether higher absolute or patient-specific EtCO targets during CPR improve resuscitation outcomes compared with the standard EtCO threshold in ED cardiac arrest patients. TRIAL REGISTRATION: Thai Clinical Trials Registry (TCTR), TCTR20240619001, registered on 19 June 2024: https://www.thaiclinicaltrials.org/show/TCTR20240619001.
High-flow nasal cannula versus continuous positive airway pressure for initial respiratory support in very preterm infants: study protocol for a multicenter randomized controlled trial (SIMPLSAFE3).
Lamberska T, Jonas K, Borcinova M … +2 more , Ophir Y, Plavka R
Trials · 2026 Jun · PMID 42286746 · Full text
BACKGROUND: Non-invasive continuous positive airway pressure (CPAP) is the standard initial respiratory support for preterm infants. However, requirements such as optimal pressure delivery and facemask repositioning, whi...
BACKGROUND: Non-invasive continuous positive airway pressure (CPAP) is the standard initial respiratory support for preterm infants. However, requirements such as optimal pressure delivery and facemask repositioning, which trigger unwanted reflexes and bradycardia, often necessitate the use of positive pressure ventilation (PPV). Findings from a pilot study suggested that high-flow nasal cannula (HFNC) may be a promising alternative to CPAP, with lower PPV requirements. We hypothesize that HFNC is a safe, effective, and user-friendly alternative to CPAP for stabilizing very preterm infants (28 + 0-31 + 6 weeks of gestation), potentially reducing the need for PPV. We aim to compare HFNC and CPAP as initial respiratory support strategies at birth. METHODS: This is a multicenter, randomized, stepped-wedge cluster trial. Infants will receive either HFNC (8 L/min) or CPAP (6 cmHO) immediately after birth with tactile stimulation. The fraction of inspired oxygen (FiO) will start at 0.30. PPV will be initiated if bradycardia or persistently low oxygen saturation (SpO) occurs. The primary outcome is stabilization with the assigned support without PPV administration. Secondary outcomes include (A) achievement of SpO ≥ 80% at 5 min (with ≤ 2 brief PPV episodes) as a surrogate of safety and (B) achievement of SpO > 90% with FiO ≤ 0.40 at 10 min as a surrogate of efficacy. Overall, 446 infants will be recruited in both arms, with an estimated study duration of 2 years. DISCUSSION: The findings may inform future respiratory support guidelines for very preterm infants at birth. TRIAL REGISTRATION: ClinicalTrials.gov NCT06543589. Registered on August 9, 2024.
6-mm versus 10-mm covered self-expandable metal stents and plastic stents for malignant distal biliary obstruction in resectable or borderline resectable pancreatic cancer in Japan (STARDOM, JON-2402P): study protocol for a multicenter randomized controlled trial.
Yamashige D, Hijioka S, Yasuda I … +5 more , Hayashi N, Taguri M, Ueno M, Furuse J, Japan Oncology Network in Hepatobiliary and Pancreas
Trials · 2026 Jun · PMID 42286634 · Full text
BACKGROUND: Pancreatic cancer is one of the most lethal malignancies; patients with resectable (R) or borderline resectable (BR) disease are treated with neoadjuvant chemotherapy (NAC) followed by surgery. In those with...
BACKGROUND: Pancreatic cancer is one of the most lethal malignancies; patients with resectable (R) or borderline resectable (BR) disease are treated with neoadjuvant chemotherapy (NAC) followed by surgery. In those with distal biliary obstruction, preoperative biliary drainage enables the timely initiation and completion of NAC followed by surgery. The optimal stent type remains undetermined; 10-mm covered self-expandable metal stents (CSEMS) provide long patency but increase the risk of cholecystitis and pancreatitis, whereas plastic stents (PS) are safer but have shorter patency. A 6-mm CSEMS potentially offers a balanced option that reduces adverse events while maintaining patency during the preoperative period. The STARDOM trial is designed to determine whether 6-mm CSEMS can maintain stent patency while reducing adverse events in preoperative biliary drainage for R/BR pancreatic cancer with distal biliary obstruction. METHODS: In a multicenter, open-label, three-arm superiority randomized controlled trial at 89 institutions across Japan, including academic hospitals and high-volume referral centers, 330 adult patients (≥ 18 years) with R/BR pancreatic cancer and distal biliary obstruction requiring preoperative biliary drainage will be recruited by investigators at each participating institution and randomly assigned (1:1:1) to receive either a 10-mm CSEMS, PS (7Fr or 8.5Fr), or 6-mm CSEMS. Patients with severe acute cholangitis or gastrointestinal obstruction will be excluded. Randomization will be stratified by institution, resectability status, and history of cholecystectomy. The primary endpoint is the event-free survival proportion at 12 weeks, defined as the absence of stent-related events including recurrent biliary obstruction (RBO), pancreatitis, cholecystitis, non-occlusive cholangitis, gastrointestinal bleeding, aspiration pneumonia, liver abscess, perforation, or death. Secondary endpoints include the event incidence rate at 12 weeks, event-free survival proportion, and event incidence rate at 12 and 24 weeks in R and BR patients, respectively; the proportion and incidence rate of each primary endpoint component; technical and clinical success; re-intervention success; and surgical outcomes such as surgical resection proportion, operative time, blood loss, postoperative complications, hospital stay, R0 resection proportion, vascular invasion, and lymph node metastasis. DISCUSSION: The STARDOM trial is a nationwide multicenter randomized controlled study to directly compare 6-mm CSEMS with conventional 10-mm CSEMS and PS in the pancreatic cancer preoperative setting. Clarifying the optimal drainage method potentially improves perioperative safety, ensures uninterrupted NAC, and supports better oncosurgical outcomes in patients with R/BR pancreatic cancer. TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT ID: jRCT1042250093; registered on August 9, 2025). Trial registry URL: https://jrct.mhlw.go.jp/latest-detail/jRCT1042250093. First planned enrollment: August 25, 2025.
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