Clinical trial NCT05857514: Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Moti Lal Nehru Medical College
Sponsor class: OTHER_GOV
First posted: 2023-05-12
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].


Eligibility criteria: 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 -

Primary outcomes:
measure: To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Allahābād
country: India
facility: Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital
state: Uttar Pradesh
city: Allahābād
country: India
facility: Department of Gastroenterology and Hepatology
state: Uttar Pradesh
Study officials:
affiliation: Investigator
name: Mukti Pr Meher, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: