Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial)

Postponed or immediate drainage of infected necrotizing pancreatitis: a pragmatic parallel group randomized controlled multicenter superiority trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33682933

Enrollment

104

Registered

2015-08-06

Start date

2015-08-04

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected necrotizing pancreatitis Digestive System

Interventions

Immediate catheter drainage after diagnosing infected necrosis while starting antibiotic treatment versus current standard treatment with postponing catheter drainage under antibiotic treatment (prefe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 12/04/2021: 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. Previous primary outcome measure: The Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after	—

Measure

Time frame

Current primary outcome measure as of 12/04/2021: 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. Previous primary outcome measure: The Comprehensive Complication Index (CCI), including all complications between randomization and 6 months after

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Secondary

Measure	Time frame
Current secondary outcome measures as of 12/04/2021: 1. Mortality 2. New onset (multi-)organ failure 3. Bleeding requiring intervention 4. Perforation of a visceral organ requiring intervention 5. Enterocutaneous fistula 6. Pancreaticocutaneous fistula 7. Incisional hernia 8. Wound infections 9. Endocrine and exocrine pancreas insufficiency 10. Number of patients with severe complications (Clavien-Dindo III or higher) 11. Number of patients per Clavien-Dindo classification 12. Number of surgical, endoscopic and radiologic interventions 13. Length of hospital stay 14. Length of ICU admission 15. QALYs 16. Total direct and indirect costs 17. Budget impact All secondary endpoints occurring within 6 months after randomization will be measured Previous secondary outcome measures: 1. Mortality 2. New onset (multi-)organ failure 3. Bleeding requiring intervention 4. Perforation requiring intervention 5. Fistula 6. Incisional hernia 7. Wound infections 8. Endocrine and exocrine pancreas insufficiency 9. Number of patients with severe complications (Clavien-Dindo III or higher) 10. Number of patients per Clavien-Dindo classification 11. Number of (re-)interventions 12. Hospital and ICU length of stay 13. QALYs 14. (In)direct costs 15. Budget impact All secondary endpoints occurring within 6 months after randomization will be measured.	—

Measure

Time frame

Current secondary outcome measures as of 12/04/2021: 1. Mortality 2. New onset (multi-)organ failure 3. Bleeding requiring intervention 4. Perforation of a visceral organ requiring intervention 5. Enterocutaneous fistula 6. Pancreaticocutaneous fistula 7. Incisional hernia 8. Wound infections 9. Endocrine and exocrine pancreas insufficiency 10. Number of patients with severe complications (Clavien-Dindo III or higher) 11. Number of patients per Clavien-Dindo classification 12. Number of surgical, endoscopic and radiologic interventions 13. Length of hospital stay 14. Length of ICU admission 15. QALYs 16. Total direct and indirect costs 17. Budget impact All secondary endpoints occurring within 6 months after randomization will be measured Previous secondary outcome measures: 1. Mortality 2. New onset (multi-)organ failure 3. Bleeding requiring intervention 4. Perforation requiring intervention 5. Fistula 6. Incisional hernia 7. Wound infections 8. Endocrine and exocrine pancreas insufficiency 9. Number of patients with severe complications (Clavien-Dindo III or higher) 10. Number of patients per Clavien-Dindo classification 11. Number of (re-)interventions 12. Hospital and ICU length of stay 13. QALYs 14. (In)direct costs 15. Budget impact All secondary endpoints occurring within 6 months after randomization will be measured.

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026