RecruitingPhase 3

Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

India140 participantsStarted 2026-04-10

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Underlying chronic pancreatitis * Recurrent acute pancreatitis * Pancreatic cancer * Patients being discharged with NJ tubes * Pregnancy and lactation * Inability to give informed consent.

What they're measuring

Percent change in body weight

Timeframe: 3 months

Trial details

NCT IDNCT07441824

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Abdul Rasheed, PharmD

+919652104726 abdulrasheedmd1223@gmail.com

View on ClinicalTrials.gov More Acute Necrotizing Pancreatitis trials