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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal indomethacin | Active Comparator |
| |
| Pancreatic duct stent and rectal indomethacin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectal Indomethacin | Drug | Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis |
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| 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 |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mukti Pr Meher, MBBS, MD | Contact | 9556694521 | 9178719869 | drmuktiprakash@gmail.com |
| Sugata N Biswas, MBBS, MD DM | Contact | 9007073201 | biswassugatan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mukti Pr Meher, MBBS, MD | Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital | Not yet recruiting | Allahābād | Uttar Pradesh | 211001 | India |
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| Prophylactic Pancreatic duct stenting | Procedure | Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis |
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| Department of Gastroenterology and Hepatology | Recruiting | Allahābād | Uttar Pradesh | 211001 | India |
|