No registrations found.
ID
Source
Brief title
Health condition
Infected necrotizing pancreatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is composite of death and major complications, defined as new onset organ failure (cardiac, pulmonary or renal), incisional hernia, bleeding requiring intervention, perforation of a visceral organ requiring intervention or enterocutaneous fistula requiring intervention.
Secondary outcome
The secondary clinical endpoints contain the separate individual components of the primary endpoint, pancreaticocutaneous fistula, recurrent pancreatitis, chronic pancreatitis according to the M-ANNHEIM diagnostic criteria, the need for additional catheter drainage or necrosectomy (either endoscopic or surgical), the total number of surgical, endoscopic or radiological (re-)interventions, biliary strictures, wound infections and exocrine and/or endocrine pancreatic insufficiency.
Background summary
The ExTENSION studies the long-term clinical outcomes in patients after severe acute necrotizing pancreatitis. This long-term follow-up study is performed 5-9 years after patients enrolled in the TENSION trial. Patients underwent a surgical or endoscopic minimally invasive step-up approach to treat the infected (peri)pancreatic necrosis. The TENSION trial showed no difference in primary endpoints composite of death and major complications between groups. However, length of hospital stay was shorter and costs were lower in the endoscopy group. Therefore, current guidelines advise if feasible, to drain the necrotic collection endoscopically and if needed, to be followed by endoscopic necrosectomy. The surgical step-up approach consisted of percutaneous drainage and if needed, followed by VARD (video assisted retroperitoneal debridement). Out of the 98 patients, 15 patients died, leaving 83 eligible for follow-up. In this follow-up study we will research the long-term outcomes of the same endpoints as in the initial study.
Study objective
A minimally invasive endoscopic step-up approach remains preferable over the surgical step-up approach to treat infected (peri)pancreatic necrosis. In the long term we expect no differences in the primary endpoint composite of death and major complications. The costs are expected to be lower in the endoscopy group.
Study design
At least 5 years after randomization. The follow-up up ends after the visit.
Intervention
Collection of stool samples, sample of blood is drawn and quality of life questionnaires will be obtained.
Inclusion criteria
surviving patients of the TENSION trial who signed IFC
Exclusion criteria
patients not willing to participate
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8571 |
| Other | METC AMC : B2020134 |