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.
≥18 years
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.
<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.
Parallel
Plastic double pigtail stent
DeviceEUS-guided placement of plastic double pigtail stent in fluid collection.
Percutaneous catheter
DevicePercutaneous catheter with external collection bag is placed in the fluid collection
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.
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.
Quality of life by the Mental Component Score (MCS) 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 MCS outcomes scores range from 0-100. Scores of 0 indicate a poor health condition, while a score of 100 indicates good health. The MCS is described by the following 4 domains: vitality, social functioning, emotional role limitation and mental health.
Quality of life by the Physical Component Summary (PCS) from the 12-Item Short Form Survey for quality of life (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.
Quality of life by the Numeric Rating Score (NRS)
The NRS is an 11-point scale from 0 to 10, measuring pain. One number can be chosen to define the pain severity. 0 is defined as no pain, while 10 is the worst pain imagineable.
Quality of life by the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)
The EQ-5D-5L questionnaire measures 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions have 5 levels ranging from no problems to extreme problems. Each answer comprises a number, which forms an index at the end of the survey which can be translated to the quality of life outcome. Lastly, a visual analogue scale (VAS) records self-reported health from 0-100, the lowest defined as "the worst health you can imagine", while the highest is defined as "the best health you can imagine".
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
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
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