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Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Sponsor: Asian Institute of Gastroenterology, India
Summary
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.
Official title: Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-04-10
Completion Date
2027-06
Last Updated
2026-05-05
Healthy Volunteers
No
Interventions
Pancreatic enzyme capsules
Enteric coated pancreatic enzyme
Placebo
Similar appearing glucose capsules
Locations (4)
Gauhati Medical College
Guwahati, Assam, India
Asian Institute of Gastroenterology Hospitals, Gachibowli
Hyderabad, Telangana, India
Asian Institute of Gastroenterology, Banjara Hills
Hyderabad, Telangana, India
ILS Hospital, Dum Dum
Kolkata, West Bengal, India