Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial
Asian Institute of Gastroenterology, India
140 participants
Apr 10, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria
- Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening
- Within 6 weeks of onset of disease
- Able to take food orally
- Age 18-60 years
- Both genders
Exclusion Criteria6
- Underlying chronic pancreatitis
- Recurrent acute pancreatitis
- Pancreatic cancer
- Patients being discharged with NJ tubes
- Pregnancy and lactation
- Inability to give informed consent.
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Interventions
Enteric coated pancreatic enzyme
Similar appearing glucose capsules
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07441824