NCT05857514

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Moti Lal Nehru Medical College · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2023-05-12
• Last updated: 2023-06-28

Locations

2 sites across 1 country: India