Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial)
- Conditions
- Digestive SystemInfected necrotizing pancreatitis
- Registration Number
- ISRCTN33682933
- Lead Sponsor
- Academic Medical Center
- Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31023380 protocol (added 29/04/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34614330/ (added 07/10/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37450701/ (added 17/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 104
Adult patients with (suspected) infected necrotizing pancreatitis; all patients with necrotizing pancreatitis will be screened for eligibility including a protocolized approach to patients with signs of infection
1. More than 35 days after onset of acute pancreatitis
2. Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding, bowel perforation, abdominal compartment syndrome)
3. Previous retroperitoneal intervention for necrotizing pancreatitis
4. Documented chronic pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Current primary outcome measure as of 12/04/2021:<br> Comprehensive Complication Index (CCI), including all complications other than pre-existent complications (e.g. treatment for infected (extra) pancreatic necrosis) occurring after randomization until 6 months after randomization, and graded according to the Clavien-Dindo classification.<br><br><br> Previous primary outcome measure:<br> The Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after<br>
- Secondary Outcome Measures
Name Time Method