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

NCT07743762 | Not Yet Recruiting DMC

• 3 other identifiers: NL-010608NL-OMON613732025.1178
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Symptomatic Fluid Collection(s)

Keywords

EUS-guided drainage; Percutaneous drainage; Endoscopic Ultrasound; Pancreas Surgery; Left pancreatectomy; Fluid collection

Outcome Measures

Primary Outcomes (2)

• Safety of procedure (absence of procedure related adverse events ≥ grade II following the Adverse Events in GI Endoscopy (AGREE) classification)

  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.

  30-day

• Co-primary: Quality of Life measured by the Physical Component Summary (PCS) from the 12-item Short Form Health Survey

  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.

  30-day

Secondary Outcomes (25)

• 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

Study Arms (2)

Endoscopic ultrasound (EUS)-guided drainage

EXPERIMENTAL

Device: Plastic double pigtail stent

Percutaneous catheter drainage

ACTIVE COMPARATOR

Device: Percutaneous catheter

Interventions

Percutaneous catheter DEVICE

Percutaneous catheter with external collection bag is placed in the fluid collection

Percutaneous catheter drainage

Plastic double pigtail stent DEVICE

EUS-guided placement of plastic double pigtail stent in fluid collection.

Endoscopic ultrasound (EUS)-guided drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Leiden University Medical Center: collaborator
• Radboud University Medical Center: collaborator
• St. Antonius Hospital: collaborator
• OLVG: collaborator
• University Medical Center Groningen: collaborator
• Maastricht University Medical Center: collaborator
• Medisch Spectrum Twente: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• University Hospital Heidelberg: collaborator
• Erasmus Medical Center: collaborator
• IRCCS San Raffaele: collaborator
• Orlando Health, Inc.: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Hospital, Ghent: collaborator

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Interventions

Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Inge de Vries

CONTACT

+31204440613; i.devries@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 4, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)