Post-ERCP Acute Pancreatitis
Conditions
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 \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].
Interventions
Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis
PROCEDUREProphylactic Pancreatic duct stenting
Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis
Sponsors
Moti Lal Nehru Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Suspected sphincter of Oddi dysfunction 2. History of post ERCP Pancreatitis 3. Pancreatic instrumentation or sphincterotomy. 4. Precut sphincteroyomy 5. Difficult cannulation defined by more than 5 cannulation attempts 6. The use of double wire technique in bile duct access 7. At least 2 of the followings including 1. Female age \< 50 year 2. 3 pancreatogram 3. Acinarization (Contrast injection to tail of pancreas 4. Normal serum bilirubin 5. Guidewire to the tail of pancreas or secondary branches
Exclusion criteria
1. Patient planned for pancreatic stenting 2. Without informed consent 3. Age \< 18 years 4. Pregnant women 5. Lactating women 6. Patient with altered anatomy 7. Contraindications to the use of NSAIDS 8. Renal failure 9. Ongoing or recent hospitalisation for acute pancreatitis 10. Allergy to aspirin or NSAIDs 11. known chronic calcific pancreatitis -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis | 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. |
Countries
India
Contacts
Primary ContactMukti Pr Meher, MBBS, MD
Backup ContactSugata N Biswas, MBBS, MD DM
Outcome results
None listed