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

Not Applicable

Recruiting

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Procedure: Prophylactic Pancreatic duct stenting; Drug: Rectal Indomethacin

• Registration Number: NCT05857514
• Lead Sponsor: Moti Lal Nehru Medical College

Brief Summary

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 \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-05-04
• Study Start: 2023-05-10
• Study First Posted: 2023-05-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-28
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreatic duct stent and rectal indomethacin	Prophylactic Pancreatic duct stenting	-
Rectal indomethacin	Rectal Indomethacin	-

Primary Outcome Measures

Name	Time	Method
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis	24 hour	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.

Trial Locations

Locations (2)

Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital; 🇮🇳 Allahābād, Uttar Pradesh, India

Department of Gastroenterology and Hepatology; 🇮🇳 Allahābād, Uttar Pradesh, India