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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
EUS-guided placement of plastic double pigtail stent in fluid collection.
Percutaneous catheter with external collection bag is placed in the fluid collection
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
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.
Time frame: 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.
Time frame: 30-day
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.
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)
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.
Time frame: Baseline, day 7, day 30, day 90
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.
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)
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".
Time frame: Baseline, day 7, day 30, day 90
Clinical success, relief of presenting symptoms or resolution of collection on imaging
Presenting symptoms such as abdominal pain, persistent nausea, suspected infection/sepsis. Resolution on cross-sectional imaging.
Time frame: 30 days
Technical success index procedure
Defined as successful completion of the intended index procedure
Time frame: During index procedure
Confirmed postoperative pancreatic fistula rate (POPF)
Following after amylase testing in collected fluid \>3 times normal upper serum limit.
Time frame: During 90-day follow-up
Postoperative pancreatic fistula (POPF) classification
After confirmed POPF, following the International Study Group for Pancreatic Surgery (ISGPS) classification. The classification has 3 grades, the lowest is ungraded: the biochemical leak or fistula, which has no clinical consequence. Subsequent grade B and C entail a clinical relevant change in therapy and confirmed amylase testing, where grade C is most severe with unfavourable outcomes (1 or more of the following: re-operation, organ failure, mortality).
Time frame: During 90-day follow-up
Timing of diagnosis postoperative pancreatic fistula (POPF)
Confirmed by amylase testing, in days after surgery
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
Timing of diagnosis fluid collection
Days after pancreatic surgery
Time frame: Pre-procedure
Timing of indication for drainage fluid collection
Per the treatment team
Time frame: Pre-procedure
Time to relief of initial symptoms
in days, such as: symptoms of abdominal pain and/or persistent nausea, suspected infection/sepsis
Time frame: During 90-day follow-up
Prophylactic drain placement rate
Time frame: Pre-procedure
Prophylactic drain removal time
In days after drain placement
Time frame: Pre-procedure
Mortality
General and (un)related
Time frame: During 90-day follow-up
Number of adverse events and serious adverse events following the Adverse Events in GI Endoscopy (AGREE) classification.
The AGREE-grading is 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 post-procedural course, grade V defined by the death of a patient.
Time frame: 30-day, 90-day
Concurrence between local physicians and expert panel
In case of acute situations
Time frame: Pre-procedural
Initial discharge location following hospital discharge
Discharge locations: home, home with home care, rehabilitation facility, nursing facility or hospice care.
Time frame: During 90-day follow-up
New onset of organ failure rate
Time frame: During 90-day follow-up
Attainability performing index procedure <24-48 hours after drainage indication
After the indication for drainage of the fluid collection has been set, it is measured that the index procedure is performed by the center within \<24-48 hours.
Time frame: Index procedure
Presence of delayed gastric emptying (DGE)
According to the International Study Group of Pancreatic Surgery (ISGPS) classification. The classification has 3 grades (A, B, C), increasing in severity. The grades address the nasogastric tube duration, toleration of solid oral intake, vomiting/gastric distension presence and the use of prokinetics.
Time frame: Pre-intervention and through study completion, which is 3 months after index procedure
Symptomatic recurrence rate
After relief of initial symptoms
Time frame: During 90-day follow-up
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