Actively Recruiting
Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Led by Asian Institute of Gastroenterology, India · Updated on 2026-05-05
140
Participants Needed
4
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and at least 5% loss of body weight. The primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.
CONDITIONS
Official Title
Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with acute pancreatitis according to the Revised Atlanta Classification
- Acute pancreatitis episode with over 50% pancreatic tissue necrosis and at least 5% body weight loss
- Within 6 weeks of disease onset
- Able to eat food by mouth
- Aged between 18 and 60 years
- Both male and female participants
You will not qualify if you...
- Chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients discharged with nasojejunal (NJ) tubes
- Pregnancy or breastfeeding
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Gauhati Medical College
Guwahati, Assam, India, 781032
Actively Recruiting
2
Asian Institute of Gastroenterology Hospitals, Gachibowli
Hyderabad, Telangana, India, 500032
Actively Recruiting
3
Asian Institute of Gastroenterology, Banjara Hills
Hyderabad, Telangana, India, 500082
Actively Recruiting
4
ILS Hospital, Dum Dum
Kolkata, West Bengal, India, 700080
Actively Recruiting
Research Team
A
Abdul Rasheed, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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