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RECRUITING
NCT07441824
PHASE3

Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

Sponsor: Asian Institute of Gastroenterology, India

View on ClinicalTrials.gov

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

DRUG

Pancreatic enzyme capsules

Enteric coated pancreatic enzyme

DRUG

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