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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857514
• Other study ID #: ECR/922/inst/UP/RR-2
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Moti Lal Nehru Medical College
• Contact: Mukti Pr Meher, MBBS, MD
• Phone: 9556694521
• Email: drmuktiprakash[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Drug:
• Rectal Indomethacin
Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis

Procedure:
• Prophylactic Pancreatic duct stenting
Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis

Locations

Country	Name	City	State
India	Department of Gastroenterology and Hepatology	Allahabad	Uttar Pradesh
India	Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital	Allahabad	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Moti Lal Nehru Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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