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

Study Overview
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Brief Summary
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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].

Official Title
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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

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Rectal Indomethacin
* Procedure: Prophylactic Pancreatic duct stenting


Participation Criteria
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Eligibility Criteria
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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 Normal serum bilirubin Guidewire to the tail of pancreas or secondary branches 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 known chronic calcific pancreatitis -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectal indomethacin<br> | Drug: Rectal Indomethacin<br>* Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis<br>|
| Active Comparator: Pancreatic duct stent and rectal indomethacin<br> | Procedure: Prophylactic Pancreatic duct stenting<br>* Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis<br>* Other names: Rectal indomethacin 100 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |