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To compare whether single collection or multiple collections requires drainage in patients with acute pancreatitis

To compare outcome of sequential versus simultaneous drainage of multiple infected collections in a patient of acute necrotizing pancreatitis: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043878
Enrollment
60
Registered
2022-07-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: K85- Acute pancreatitis

Interventions

Intervention1: Simultaneous drainage: In simultaneous drainage arm, all the collections which are amenable for drainage will be drained simultaneously. The route of drainage (endoscopic or percutaneou

Sponsors

No sponser
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients of acute necrotizing pancreatitis with 1. Illness of more than 1 week duration 2. Two or more drainable collections at different locations as per definition given below 3. No response to antibiotic therapy for 72 hours. 4. Indication of drainage which will include 1. Persistent systemic inflammatory response syndrome (SIRS) 2. Clinically suspected or proven infected pancreatic necrosis 3. Persistent or new onset organ failure

Exclusion criteria

Exclusion criteria: All patients with acute necrotizing pancreatitis with 1. Patients aged 2. Duration of illness less than 1 week 3. Patients with asymptomatic collections 4. Single collection 5. Patients requiring drainage of collection due to only pressure symptoms like abdominal pain, biliary obstruction or gastric outlet obstruction 6. Previous intervention in any of the collections (drainage of ascites and pleural effusion will not be an exclusion criteria) 7. Patients who do not give consent

Design outcomes

Primary

MeasureTime frame
Comprehensive Complications Index (CCI), including all complications other than pre-existent complications (e.g. treatment for infected collection) occurring after randomization till the removal of all drains (percutaneous or endoscopic) or discharge whichever is later, and graded according to the Clavien-Dindo classificationTimepoint: At discharge or removal of catheter

Secondary

MeasureTime frame
Bleeding requiring interventionTimepoint: At discharge or removal of all catheters;Enterocutaneous and pancreatic fistula Timepoint: At discharge or removal of all catheters;Length of hospital stay and length of ICU stay after randomization Timepoint: At discharge ;MortalityTimepoint: Hospital mortality;New-onset (single or multiple) organ failureTimepoint: At discharge or removal of all catheters;Number of endoscopic and radiological interventions Timepoint: At discharge or removal of all catheters ;Perforation of a visceral organ requiring interventionTimepoint: At discharge or removal of all catheters;Requirement of surgical intervention Timepoint: At discharge or removal of all catheters

Countries

India

Contacts

Public ContactJimil Shah

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

shahjimil22@gmail.com08655376773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026