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
Overview
- Phase
- Not Applicable
- Intervention
- Rectal Indomethacin
- Conditions
- Post-ERCP Acute Pancreatitis
- Sponsor
- Moti Lal Nehru Medical College
- Enrollment
- 384
- Locations
- 2
- Primary Endpoint
- To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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].
Investigators
Mukti Prakash Meher
Principal investigator
Moti Lal Nehru Medical College
Eligibility Criteria
Inclusion Criteria
- •Suspected sphincter of Oddi dysfunction
- •History of post ERCP Pancreatitis
- •Pancreatic instrumentation or sphincterotomy.
- •Precut sphincteroyomy
- •Difficult cannulation defined by more than 5 cannulation attempts
- •The use of double wire technique in bile duct access
- •At least 2 of the followings including
- •Female age \< 50 year
- •3 pancreatogram
- •Acinarization (Contrast injection to tail of pancreas
Exclusion Criteria
- •Patient planned for pancreatic stenting
- •Without informed consent
- •Age \< 18 years
- •Pregnant women
- •Lactating women
- •Patient with altered anatomy
- •Contraindications to the use of NSAIDS
- •Renal failure
- •Ongoing or recent hospitalisation for acute pancreatitis
- •Allergy to aspirin or NSAIDs
Arms & Interventions
Rectal indomethacin
Intervention: Rectal Indomethacin
Pancreatic duct stent and rectal indomethacin
Intervention: Prophylactic Pancreatic duct stenting
Outcomes
Primary Outcomes
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
Time Frame: 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.