Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis

A Prospective, Open Label Randomized Controlled Trial of Prophylactic Rectal Indomethacin Versus Combined Pancreatic Duct Stent Placement and Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis

The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.

If there is a comparison group: Researchers will compare [rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.] to see if [whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis].

Study Overview

• Status: Recruiting
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Drug: Rectal Indomethacin; Procedure: Prophylactic Pancreatic duct stenting

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mukti Pr Meher, MBBS, MD; Phone Number: 9178719869 9556694521; Email: drmuktiprakash@gmail.com
• Study Contact Backup: Name: Sugata N Biswas, MBBS, MD DM; Phone Number: 9007073201; Email: biswassugatan@gmail.com

Study Locations

• India
  • Uttar Pradesh
    • Allahābād, Uttar Pradesh, India, 211001
      • Not yet recruiting
      • Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital
      • Contact: Mukti Pr Meher, MBBS, MD; Phone Number: 9178719869 9556694521; Email: drmuktiprakash@gmail.com
    • Allahābād, Uttar Pradesh, India, 211001
      • Recruiting
      • Department of gastroenterology and hepatology
      • Contact: Mukti Pr Meher, MD; Phone Number: 9178719869 9556694521; Email: drmuktiprakash@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Suspected sphincter of Oddi dysfunction
2. History of post ERCP Pancreatitis
3. Pancreatic instrumentation or sphincterotomy.
4. Precut sphincteroyomy
5. Difficult cannulation defined by more than 5 cannulation attempts
6. The use of double wire technique in bile duct access

7. At least 2 of the followings including

   1. Female age < 50 year
   2. 3 pancreatogram
   3. Acinarization (Contrast injection to tail of pancreas
   4. Normal serum bilirubin
   5. Guidewire to the tail of pancreas or secondary branches

Exclusion Criteria:

1. Patient planned for pancreatic stenting
2. Without informed consent
3. Age < 18 years
4. Pregnant women
5. Lactating women
6. Patient with altered anatomy
7. Contraindications to the use of NSAIDS
8. Renal failure
9. Ongoing or recent hospitalisation for acute pancreatitis
10. Allergy to aspirin or NSAIDs
11. known chronic calcific pancreatitis -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rectal indomethacin	Drug: Rectal Indomethacin; Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis
Active Comparator: Pancreatic duct stent and rectal indomethacin	Procedure: Prophylactic Pancreatic duct stenting; Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis; Other Names: Rectal indomethacin 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis	For comparison between these two arms the investigators will measure serum amylase in U/L value after 6 hour and 24 hour of the ERCP procedure. The investigators will also assess for pain abdomen and vomiting suggestive of acute pancreatitis.	24 hour

Collaborators and Investigators

• Sponsor: Moti Lal Nehru Medical College
• Investigators: Principal Investigator: Mukti Pr Meher, MBBS, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: ECR/922/inst/UP/RR-2

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