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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• ≥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.

Exclusion criteria

• <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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Amsterdam UMC, location VUmc — Amsterdam

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗