Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial (PERiANP)

NCT07441824 Phase 3 RECRUITING

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.

Details

Lead sponsor	Asian Institute of Gastroenterology, India
Phase	Phase 3
Status	RECRUITING
Enrolment	140
Start date	2026-04-10
Completion	2027-06

Conditions

• Acute Necrotizing Pancreatitis
• Pancreatic Exocrine Insufficiency

Interventions

• Pancreatic enzyme capsules
• Placebo

Primary outcomes

• Percent change in body weight — 3 months
  Body weight (in kg) will be measured at baseline and again at 3 months follow-up, and the difference between the two time points will be used to assess the effect of the intervention on patients' weight status. The change will be expressed as percent change of weight 3 months compared to baseline weight.

Countries

India