Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and… (NCT05857514) | Clinical Trial Compass
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Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis
India384 participantsStarted 2023-05-10
Plain-language 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 \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
✕. Patient planned for pancreatic stenting
✕. Without informed consent
✕. Age \< 18 years
✕. Pregnant women
What they're measuring
1
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis