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Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

RecruitingPhase 3Ages 18 Years - 60 YearsAllAsian Institute of Gastroenterology, India
NCT07441824 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pancreatic enzyme capsules
  • Placebo
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Where

4 sites
Gauhati Medical College
Guwahati, India
Asian Institute of Gastroenterology Hospitals, Gachibowli
Hyderabad, India
Asian Institute of Gastroenterology, Banjara Hills
Hyderabad, India
ILS Hospital, Dum Dum
Kolkata, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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