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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
2026-02
Completion Date
2027-06
Last Updated
2026-03-02
Healthy Volunteers
No
Interventions
Pancreatic enzyme capsules
Enteric coated pancreatic enzyme
Placebo
Similar appearing glucose capsules
Locations (1)
Asian Institute of Gastroenterology Hospitals
Hyderabad, Telangana, India