Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy
Starting soon · Not applicable
Conditions studied: Symptomatic Fluid Collection(s)
In brief
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.
Key facts
- Study ID
- NCT07743762
- Run by
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- People needed
- 96
- Starts
- 2026-08-01
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Amsterdam UMC, location VUmc — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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