PERT in Acute Necrotizing Pancreatitis
Trial statusNot yet recruiting
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, 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Underlying chronic pancreatitis
Recurrent acute pancreatitis
Pancreatic cancer
Patients being discharged with NJ tubes
Trial design
Treatments tested in this trial
- Pancreatic Enzyme Replacement Therapy
- Placebo
Treatment groups
188 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov