Complication: Postoperative (peri)pancreatic fluid collections, symptomatic fluid collection(s), Postoperative pancreatic fistula, Postoperative pancreatic fistula collection. Surgery type: left pancreatectomy, distal pancreatectomy, pancreatic tail resection. Complication: Pancreatic fluid pockets, fluid collections near the pancreas, digestive gland fluid collection. Surgery: digestive gland surgery
Conditions
Interventions
Comparison between percutaneous drainage with an external drain versus EUS-guided drainage with plastic stent placement.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: =18 yearsSymptomatic fluid collection following a left pancreatectomy, with an indication for drainage according to the treatment team. Indications for drainage exists of: Symptoms of abdominal pain and/or persistent nausea. Suspected infection/ sepsis. Fluid collection drainage is endoscopically and percutaneously feasible, preferably judged by the expert panel, to ensure the possibility that participants can be randomized between both treatment modalities. 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 for the fluid collection. In case of a previously intraoperatively placed drain, it should have been removed 5 days prior to fluid collection development.
Exclusion criteria
Exclusion criteria: <18 yearsThe fluid collection is not endoscopically or percutaneously feasible per the expert panel’s judgement or the treatment team in acute situations.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.Unable to obtain informed consent by either patient or their legal representative. Permanently incapacitated research participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is safety by day 30 after index procedure, defined as absence of procedure related adverse-events. The co-primary endpoint is quality of life at 30 days, and is additionally measured in intervals until day 90 after index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include and are not limited to: hospital stay duration, feasibility of intervention within 48 hours, reintervention rate and mortality. | — |
Countries
Belgium, Germany, Italy, Netherlands, Sweden, United States
Contacts
Public ContactR.P. Voermans
Amsterdam UMC
Outcome results
None listed