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

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)

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• St. Antonius Hospital

  collaborator OTHER

• OLVG

  collaborator NETWORK

• University Medical Center Groningen

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Medisch Spectrum Twente

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• University Hospital Heidelberg

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• IRCCS San Raffaele

  collaborator OTHER

• Orlando Health, Inc.

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2029-11-01

Completion

2030-05-01

Countries

• Netherlands

Study Locations