Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAsian Institute of Gastroenterology, India
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Underlying chronic pancreatitis
Recurrent acute pancreatitis
Pancreatic cancer
Patients being discharged with NJ tubes
Trial design
Treatments tested in this trial
- Pancreatic enzyme capsules
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov