Not Yet RecruitingPhase 3

PERT in Acute Necrotizing Pancreatitis

188 participantsStarted 2025-10-01

Plain-language summary

In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with \>50% pancreatic parenchymal necrosis and \>10% loss of body weight. The primary outcome measure is change in BMI 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

See this in plain English?

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 at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening * Within 28 days of onset of disease * 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

Change in Body Mass Index (BMI)

Timeframe: 3 months

Trial details

NCT IDNCT07211568

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Abdul Rasheed, PharmD

+919652104726 abdulrasheedmd1223@gmail.com

View on ClinicalTrials.gov More Acute Pancreatitis Necrotizing trials