Comparing two methods to prevent pancreatitis after ERCP

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

This study is testing whether using just rectal indomethacin or a combination of pancreatic duct stenting and rectal indomethacin is better at preventing pancreatitis in patients undergoing ERCP.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 384 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Moti Lal Nehru Medical College (other gov)
• Locations: 2 sites (Allahābād, Uttar Pradesh and 1 other locations)
• Trial ID: NCT05857514 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of rectal indomethacin alone versus a combination of pancreatic duct stenting and rectal indomethacin in preventing post-ERCP pancreatitis. Participants will include patients undergoing ERCP who meet specific inclusion criteria, such as suspected sphincter of Oddi dysfunction or a history of post-ERCP pancreatitis. The study will evaluate whether the single treatment with rectal indomethacin is superior to the combined approach in reducing the incidence of pancreatitis following the procedure.

Who should consider this trial

Good fit: Ideal candidates are patients undergoing ERCP with risk factors for post-ERCP pancreatitis, such as suspected sphincter of Oddi dysfunction.

Not a fit: Patients who are planned for pancreatic stenting or have contraindications to NSAIDs will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method for preventing post-ERCP pancreatitis, improving patient outcomes.

How similar studies have performed: While there have been studies on the use of indomethacin for pancreatitis prevention, the specific comparison of these two approaches is novel.

Eligibility criteria

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 -

Where this trial is running

Allahābād, Uttar Pradesh and 1 other locations

• Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital — Allahābād, Uttar Pradesh, India (NOT_YET_RECRUITING)
• Department of Gastroenterology and Hepatology — Allahābād, Uttar Pradesh, India (RECRUITING)

Study contacts

• Principal investigator: Mukti Pr Meher, MBBS, MD — Investigator
• Study coordinator: Mukti Pr Meher, MBBS, MD

Conditions: Post-ERCP Acute Pancreatitis