Health Condition 1: K85- Acute pancreatitis
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh