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

Sponsor
Moti Lal Nehru Medical College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05857514
Collaborator
(none)
384
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
32
Patients Per Site Per Month

Study Details

Study Description

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].

Condition or Disease Intervention/Treatment Phase
  • Drug: Rectal Indomethacin
  • Procedure: Prophylactic Pancreatic duct stenting
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
May 2, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rectal indomethacin

Drug: Rectal Indomethacin
Prophylactic Rectal indomethacin 50mg for prevention of post ERCP pancreatitis
Active Comparator: Pancreatic duct stent and rectal indomethacin

Procedure: Prophylactic Pancreatic duct stenting
Prophylactic pancreatic duct stenting with rectal indomethacin 50 mg for prevention of post-ERCP pancreatitis
Other Names:
  • Rectal indomethacin 50 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    8. Female age < 50 year

    9. 3 pancreatogram

    10. Acinarization (Contrast injection to tail of pancreas

    11. Normal serum bilirubin

    12. 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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital Allahābād Uttar Pradesh India 211001

    Sponsors and Collaborators

    • Moti Lal Nehru Medical College

    Investigators

    • Principal Investigator: Mukti Pr Meher, MBBS, MD, Investigator

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mukti Prakash Meher, Principal investigator, Moti Lal Nehru Medical College
    ClinicalTrials.gov Identifier:
    NCT05857514
    Other Study ID Numbers:
    • ECR/922/inst/UP/RR-2
    First Posted:
    May 12, 2023
    Last Update Posted:
    May 12, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatitis
    Indomethacin

    Study Results

    No Results Posted as of May 12, 2023