Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy (PERSEUS-I): an International Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification)
研究概览
简要总结
Fluid collections are a complication after pancreatic surgery. These fluid collections can be treated with two treatment options. One option is percutaneous drainage, where an external drainage tube is placed in the collection. The second option is endoscopic ultrasound-guided drainage (EUS) with a stent. Both options have similar results in previous clinical studies, but they have not been directly compared in a randomized clinical trial.
The goal of this clinical trial is to compare percutaneous drainage with EUS-guided drainage. The main questions it aims to answer are:
- Is EUS-guided drainage of symptomatic fluid collections non-inferior to percutaneous catheter drainage in terms of safety?
- Is EUS-guided drainage superior in terms of 30-day quality of life, compared to percutaneous drainage?
Researchers will compare EUS-guided drainage with percutaneous drainage to see if they are similar in safety outcomes and different in quality-of-life outcomes.
Participants will:
- Be randomized between percutaneous drainage and EUS-guided drainage.
- Fill-out surveys and pain score when they start the study, and then after 1 week and 3 months.
- Fill-out an extra pain score on day 1 and day 3.
- Receive a phone call from the study team after 1 month, where they will be asked how they are doing. Together with the study team member they fill out the surveys that are taken after 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years
- •Symptomatic fluid collection following a left pancreatectomy requiring drainage according to the treatment team. Indications for drainage exists of:
- •Symptoms of abdominal pain and/or persistent nausea.
- •Suspected infection/ sepsis
- •Drainage of the fluid collection is feasible both endoscopically and percutaneously as per the treating team. NB: Preferably this is also assessed and supported by the expert panel, but this is NOT mandatory given the potential urgent nature of the intervention. The investigators expect that multidisciplinary consultation with both intervening specialties precedes the feasibility assessment.
- •No contraindications for either procedure. If the contraindication can be overcome safely, such as ascites for which prior abdominal drainage is needed, the patient can still be included.
- •No prior drainage attempts of the fluid collection.
- •In case of a previously intraoperatively placed drain, it should have been removed 5 days prior to fluid collection development.
排除标准
- •<18 years
- •The fluid collection is not endoscopically or percutaneously feasible per the expert panel's judgement or the treatment team in acute situations, for example due to collection location too far from the gastrointestinal tract.
- •Prior drainage attempts of the fluid collection.
- •Received an indwelling percutaneous drain intraoperatively. Intraoperatively placed drains are only permitted when at least removed 5 days prior to development of the fluid collection.
- •Permanent incapacitation of research participant, prior to clinical deterioration caused by the pancreatic fluid collection, without expectation of improvement as per the treatment team.
- •Unable to obtain informed consent by either patient or their legal representative.
结局指标
主要结局
Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification)
时间窗: 30-day
Non-inferiority analysis, absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification. The AGREE-grading ranges from Grade I to Grade V. The severity of the adverse event increases with the grade, grade I is non-exhaustive defined as deviation from the post-procedural course, grade V is defined by the death of a patient.
Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey
时间窗: 30-day
Superiority analysis, measured by the Physical Component Summary (PCS) from the 12-item short form health survey (SF-12). The SF-12 measures quality of life by physical (PCS) and mental health (MCS) scores, and is an abbreviated version of the 36-item short form health survey (SF-36). The PCS outcome ranges from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The PCS is described by 4 domains: bodily functioning, physical role limitation, pain and general perceived health.
次要结局
- Quality of life by the Mental Component Score (MCS) from the 12-Item Short Form Health Survey (SF-12)(Baseline, day 7, day 30, day 90)
- Quality of life by the Physical Component Summary (PCS) from the 12-Item Short Form Survey for quality of life (SF-12)(Baseline, day 7, day 30, day 90)
- Quality of life by the Numeric Rating Score (NRS)(Baseline, day 1, day 3, day 7, 30 days, 90 days)
- Quality of life by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)(Baseline, day 7, day 30, day 90)
- Clinical success, relief of presenting symptoms or resolution of collection on imaging(30 days)
- Technical success index procedure(During index procedure)
- Confirmed postoperative pancreatic fistula rate (POPF)(During 90-day follow-up)
- Postoperative pancreatic fistula (POPF) classification(During 90-day follow-up)
- Timing of diagnosis postoperative pancreatic fistula (POPF)(During 90-day follow-up)
- Reintervention rate(During 90-day follow-up)
- Hospital and ICU stay in days(During 90-day follow-up)
- Readmission rate(During 90-day follow-up)
- Timing of diagnosis fluid collection(Pre-procedure)
- Timing of indication for drainage fluid collection(Pre-procedure)
- Time to relief of initial symptoms(During 90-day follow-up)
- Prophylactic drain placement rate(Pre-procedure)
- Prophylactic drain removal time(Pre-procedure)
- Mortality(During 90-day follow-up)
- Number of adverse events and serious adverse events following the Adverse Events in GI Endoscopy (AGREE) classification.(30-day, 90-day)
- Concurrence between local physicians and expert panel(Pre-procedural)
- Initial discharge location following hospital discharge(During 90-day follow-up)
- New onset of organ failure rate(During 90-day follow-up)
- Attainability performing index procedure <24-48 hours after drainage indication(Index procedure)
- Presence of delayed gastric emptying (DGE)(Pre-intervention and through study completion, which is 3 months after index procedure)
- Symptomatic recurrence rate(During 90-day follow-up)
研究者
Rogier P. Voermans
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)