PERT in Acute Necrotizing Pancreatitis

NCT07211568 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ANP-PERT 1
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Pancreatitis Necrotizing; Nutrition Assessment

Keywords

Nutrition in AP; PERT in AP; pancreatic exocrine insufficiency

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI)

  BMI will be measured at baseline and again at 3 months follow-up, with the difference between the two time points used to assess the effect of the intervention on patients' weight status.

  3 months

Secondary Outcomes (10)

• 1. Change in Quality of Life

  3 months

• Change in pancreatic exocrine function

  3 months

• Change in nutritional status: Anthropometry

  3 months

• Change in nutritional status: Anthropometry

  3 months

• Change in nutritional status: Biochemical assessment

  3 months

Study Arms (2)

PERT

EXPERIMENTAL

Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with food (Breakfast, lunch and dinner)

Drug: Pancreatic Enzyme Replacement Therapy

Placebo

PLACEBO COMPARATOR

Similar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner)

Drug: Placebo

Interventions

Pancreatic Enzyme Replacement Therapy DRUG

Enteric coated pancreatic enzyme preparation

PERT

Placebo DRUG

Similar appearing glucose capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Both genders

You may not qualify if:

• Underlying chronic pancreatitis
• Recurrent acute pancreatitis
• Pancreatic cancer
• Patients being discharged with NJ tubes
• Pregnancy and lactation
• Inability to give informed consent.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Related Publications (5)

• Huang W, de la Iglesia-Garcia D, Baston-Rey I, Calvino-Suarez C, Larino-Noia J, Iglesias-Garcia J, Shi N, Zhang X, Cai W, Deng L, Moore D, Singh VK, Xia Q, Windsor JA, Dominguez-Munoz JE, Sutton R. Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis. Dig Dis Sci. 2019 Jul;64(7):1985-2005. doi: 10.1007/s10620-019-05568-9. Epub 2019 Jun 4.

  PMID: 31161524 BACKGROUND

• Umapathy C, Raina A, Saligram S, Tang G, Papachristou GI, Rabinovitz M, Chennat J, Zeh H, Zureikat AH, Hogg ME, Lee KK, Saul MI, Whitcomb DC, Slivka A, Yadav D. Natural History After Acute Necrotizing Pancreatitis: a Large US Tertiary Care Experience. J Gastrointest Surg. 2016 Nov;20(11):1844-1853. doi: 10.1007/s11605-016-3264-2. Epub 2016 Sep 12.

  PMID: 27619808 BACKGROUND

• Lee PJ, Papachristou GI. New insights into acute pancreatitis. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):479-496. doi: 10.1038/s41575-019-0158-2.

  PMID: 31138897 BACKGROUND

• Wang GJ, Gao CF, Wei D, Wang C, Ding SQ. Acute pancreatitis: etiology and common pathogenesis. World J Gastroenterol. 2009 Mar 28;15(12):1427-30. doi: 10.3748/wjg.15.1427.

  PMID: 19322914 BACKGROUND

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Rupjyoti Talukdar, MD

  Asian Institute of Gastroenterology

  STUDY DIRECTOR

Central Study Contacts

Abdul Rasheed, PharmD

CONTACT

+919652104726; abdulrasheedmd1223@gmail.com

Rupjyoti Talukdar, MD

CONTACT

+917032804231; rup_talukdar@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-09