POINTER trial: postponed or immediate drainage of infected necrotizing pancreatitis

Completed

Conditions: Geïnfecteerde necrotiserende pancreatitis
Acute necrotizing pancreatitis
severe acute pancreatitis
10017969

Registration Number: NL-OMON47739

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 104

Inclusion Criteria

- Documented infected necrotizing pancreatitis
- Suspected infected necrotizing pancreatitis (if > 14 days after onset of
acute pancreatitis)
- Catheter drainage of the collection with infected necrosis is technically
feasible
- Age >= 18 years

Exclusion Criteria

- > 35 days after onset of acute pancreatitis
- Indication for emergency laparotomy for abdominal catastrophe (e.g. bleeding,
bowel perforation, abdominal compartment syndrome)
- Previous retroperitoneal intervention for necrotizing pancreatitis
- Documented chronic pancreatitis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome consists of the Comprehensive Complication Index (CCI),<br /><br>including all complications between randomization and 6 months after.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome are: mortality, new onset (multi) organ failure, bleeding<br /><br>requiring intervention, perforation requiring intervention, fistula, incisional<br /><br>hernia, wound infections, endocrine and exocrine pancreas insufficiency, number<br /><br>of patients with severe complications (Clavien-Dindo III or higher), number of<br /><br>patients per Clavien-Dindo classification, number of (re-)interventions,<br /><br>hospital and ICU length of stay, QALYs, (in)direct costs, and budget impact.</p><br>