Indian National Study to Assess Incidence and Severity of Post-ERCP Pancreatitis After Following SOP (INSPIRE)

Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery. However, despite its therapeutic efficacy, ERCP carries a significant risk of procedure-related adverse events, of which post-ERCP pancreatitis (PEP) is the most common and clinically important complication.

The reported incidence of PEP in prospective multicenter studies ranges from 7 % to 10 % in unselected populations, and may increase to 15 % or higher in high-risk subsets such as patients with difficult cannulation, sphincter of Oddi dysfunction, or a prior history of pancreatitis or PEP. Although the majority of cases are mild and self-limited, a small but important proportion (approximately 10-15 %) progress to moderate or severe disease, resulting in prolonged hospitalization, increased cost, and occasionally mortality.

Over the past two decades, extensive research has improved our understanding of PEP pathogenesis and risk stratification. Several patient-related (younger age, female sex, prior PEP or pancreatitis, sphincter of Oddi dysfunction, asymptomatic choledocholithiasis) and procedure-related (difficult cannulation, pancreatic duct contrast injection or guidewire passage, pancreatic sphincterotomy, endoscopic papillary balloon dilation) predictors have been identified.

Study Overview

• Status: Not yet recruiting
• Conditions: ERCP

• Study Type: Observational
• Enrollment (Estimated): 2366

Contacts and Locations

• Study Contact: Name: DR NITIN JAGTAP, MD,DM; Phone Number: 8712015028; Email: docsnitin13@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

2366

Description

Inclusion Criteria:

Consecutive ERCPs during the enrollment window.

• Males and females between 18 and 75 years of age who ca comprehend instructions, follow study procedures, willing to sign an informed consent form and have a clinical indication to undergo a ERCP.
• Patients undergoing ERCP for therapeutic indications
• Patients with intact papilla

Exclusion Criteria:

• patient undergoing ERCP for diagnostic indications
• Acute pancreatitis
• Previous sphincterotomy
• Altered anatomy, defined as anatomical variations in which bile and/or pancreatic secretion donot enter the duodenum by way of the ampulla of Vater
• Pregnancy
• Signs of Congestive heart failure, such as pitting edema or a NYHA classification greater than class II heart failure.
• Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation).
• Severe liver disease (cirrhosis and ascites)
• Contraindication for rectal indomethacin

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rectal NSAID Prophylaxis; Participants who receive a single dose of rectal indomethacin or diclofenac (100 mg suppository) as part of routine clinical practice. The dose is given 30 minutes before ERCP, or immediately after the procedure if the pre-procedure dose was missed.
Pancreatic Duct Stent Placement; Participants in whom the pancreatic duct is accessed during ERCP and a small plastic prophylactic pancreatic duct stent is placed as part of standard care. The stent is temporary and is expected to pass naturally or be removed within 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-ERCP pancreatitis (PEP), defined as	New or worsened abdominal pain after ERCP with serum amylase or lipase ≥3 × the upper limit of normal measured ≥24 hours post-procedure,; Accompanied by hospitalization or prolongation of hospital stay attributable to pancreatitis.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of PEP	Mild, moderate, or severe according to the Revised Atlanta Classification (based on organ failure and duration of hospitalization	30 days

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: MD NITIN JAGTAP, MD,DM, Asian Institute Of Gastroenterology Private Limited

Study record dates

Study Major Dates

• Study Start (Estimated): January 10, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: INSPIRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No