Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy

Официальное название

Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy (PERSEUS-I): an International Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство Plastic double pigtail stent
  EUS-guided placement of plastic double pigtail stent in fluid collection.
• Устройство Percutaneous catheter
  Percutaneous catheter with external collection bag is placed in the fluid collection

Первичные конечные точки

• Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification) [Срок оценки: 30-day]
• Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey [Срок оценки: 30-day]

Вторичные конечные точки (12)

• Quality of life by the Mental Component Score (MCS) from the 12-Item Short Form Health Survey (SF-12) [Срок оценки: 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) [Срок оценки: Baseline, day 7, day 30, day 90]
• Quality of life by the Numeric Rating Score (NRS) [Срок оценки: 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) [Срок оценки: Baseline, day 7, day 30, day 90]
• Clinical success, relief of presenting symptoms or resolution of collection on imaging [Срок оценки: 30 days]
• Technical success index procedure [Срок оценки: During index procedure]
• Confirmed postoperative pancreatic fistula rate (POPF) [Срок оценки: During 90-day follow-up]
• Postoperative pancreatic fistula (POPF) classification [Срок оценки: During 90-day follow-up]
• Timing of diagnosis postoperative pancreatic fistula (POPF) [Срок оценки: During 90-day follow-up]
• Reintervention rate [Срок оценки: During 90-day follow-up]
• Hospital and ICU stay in days [Срок оценки: During 90-day follow-up]
• Readmission rate [Срок оценки: During 90-day follow-up]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• <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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC, location VUmc — Amsterdam

Идентификаторы

NCT: NCT07743762 · NL-010608 · NL-OMON61373 · 2025.1178

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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