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CTRI Number  CTRI/2025/04/085484 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 01/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study comparing Pancreatic enzymes versus similar looking placebo tablets to improve outcomes in acute pancreatitis  
Scientific Title of Study   Effect of Pancreatic Enzyme Supplementation on 90-days hospital free alive days in patients with Acute Necrotizing Pancreatitis (ANP): A multicenter double blinded placebo-controlled randomizedTrial 
Trial Acronym  PEAP trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudipta Dhar Chowdhury 
Designation  Professor and Head 
Affiliation  Christian Medical College, Vellore 
Address  Department of Gastroenterology, Christian Medical College, Vellore, India Ranipet Campus, Kilminnal village, Ranipet, Tamilnadu

Vellore
TAMIL NADU
632517
India 
Phone  04172224870  
Fax    
Email  sudipta@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sudipta Dhar Chowdhury 
Designation  Professor and Head 
Affiliation  Christian Medical College, Vellore 
Address  Department of Gastroenterology, Christian Medical College, Vellore, India Ranipet Campus, Kilminnal village, Ranipet, Tamilnadu

Vellore
TAMIL NADU
632517
India 
Phone  04172224870  
Fax    
Email  sudipta@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Sudipta Dhar Chowdhury 
Designation  Professor and Head 
Affiliation  Christian Medical College, Vellore 
Address  Department of Gastroenterology, Christian Medical College, Vellore, India Ranipet Campus, Kilminnal village, Ranipet, Tamilnadu

Vellore
TAMIL NADU
632517
India 
Phone  04172224870  
Fax    
Email  sudipta@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
ICMR  
 
Primary Sponsor  
Name  The Indian Council of Medical Research 
Address  The Indian Council of Medical Research V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pramod Garg  All India Institue of Medical Sciences, Delhi   Department Of Gastroenterology All India Institute of Medical Sciences Ansari Nagar, New Delhi - 110029
South West
DELHI 		 01126588500

pgarg10@gmail.com 
Dr Sudipta Dhar Chowdhury   Christian Medical College, Vellore  Department Of Gastroenterology Christian Medical College Vellore Ranipet Campus Kilminnal Village Ranipet District Tamilnadu Pincode 632 517
Vellore
TAMIL NADU 		 9952311988

sudiptadharchowdhury@gmail.com 
Dr Jayanta Samanta  Post Graduate Institute of Medical Education & Research, Chandigarh  Department Of Gastroenterology Post Graduate Institute of Medical Education & Research, Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS Delhi  Submittted/Under Review 
OFFICE OF RESEARCH INSTITUTIONAL REVIEW BOARD (IRB) CHRISTIAN MEDICAL COLLEGE, VELLORE, INDIA  Approved 
Post Graduate Institute of Medical Education & Research, Chandigarh, Institutional Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral pancreatic enzyme supplementation  pancreatic enzyme supplementation - 2 Tablets/ meal, each containing: Equivalent to Lipase 25000 USP units, Amylase 74700 USP units, Protease 62500 USP unit. Oral administration. Duration of administration - 90 days  
Comparator Agent  Placebo  placebo -2 Tablets/meal, each similar to enzyme supplement tablets. Oral administration. Duration of administration - 90 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Acute pancreatitis with pancreatic necrosis within 14 days of pain, Able to take oral or enteral feed, pancreatic necrosis more than 30%
 
 
ExclusionCriteria 
Details  Patients with Chronic Pancreatitis, Patients with more multi-organ failure at time of screening, Patient on ventilatory support, Pregnancy, Contraindication to enteral feeding or not tolerating enteral feed, Age lesser than 18 years or more than 75 years, Major comorbidity such as decompensated cirrhosis heart failure significant lung parenchymal or airway disease advanced chronic kidney disease, Previous pancreatic surgery, Known allergy to pancreatic enzyme supplementation components







 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Days alive and out of hospital at 90 days. It will be counted as number of days the patient is not in hospital and alive. This parameter will take into account total duration of readmissions and mortality.
DAOH90= Number of days alive (within 90 days of follow up) – (Total hospitalization days at readmission). 		 90 days  
 
Secondary Outcome  
Outcome  TimePoints 
a. All cause mortality
b. Mean change in body weight from baseline in both groups
c. Mean change in mid upper arm circumference at from baseline in both groups

 		 day 30, day 60 & day 90 
 
Target Sample Size   Total Sample Size="248"
Sample Size from India="248" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The PEAP trial is a study to assess the usefulness of PERT
(pancreatic enzyme replacement therapy) in acute necrotizing pancreatitis. It is designed as a double
blind placebo controlled randomized trial to assess the 90 day alive and hospital free days in patients
with ANP. The days alive and out of hospital at 90 days (DAOH-90) is novel metric to assess
outcome in critical illness as it measures survival and length of hospital stay. Increase in DAOH 90
represents an important clinically relevant outcome.
A total of 248 patients with acute necrotizing pancreatitis will be recruited from three study sited in
India. All patients will be treated as per standard of care. At the time of discharge patients will
requested for consent to participate in the trial. After obtaining informed consent, enrolled patients will
be randomized to receive either PERT at 25000 IU with every meal or an identical placebo at
discharge. They will be followed up 2 weekly over telephone till ninety days of recruitment. The
outcome will be assessed at 90 days for – Days Alive and out of hospital at 90 days (DAOH 90 ).
DAOH 90 will be calculate as below:
DAOH 90 = Number of days alive (within 90days of follow up) – (Total hospitalization days at
readmission). In addition to the DAOH 90 we will also measure the readmission rates, nutritional status,
and quality of life.
 
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