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Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis

Study acronym: PERiANP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Trial sites expanded: 1 → 4 locations
    • Start date changed from estimate of Feb 2026 to Apr 10, 2026
    • Eligibility criteria revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07441824
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)		 Acute Necrotizing Pancreatitis, Pancreatic Exocrine Insufficiency
Related terms Exocrine Pancreatic Insufficiency, Pancreatitis, Pancreatitis, Acute Necrotizing
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov