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

Primary Purpose

Post-ERCP Acute Pancreatitis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Rectal Indomethacin
Prophylactic Pancreatic duct stenting
Sponsored by
Moti Lal Nehru Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital
  • Department of Gastroenterology and HepatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectal indomethacin

Pancreatic duct stent and rectal indomethacin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2023
Last Updated
June 25, 2023
Sponsor
Moti Lal Nehru Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05857514
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moti Lal Nehru Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectal indomethacin
Arm Type
Active Comparator
Arm Title
Pancreatic duct stent and rectal indomethacin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rectal Indomethacin
Intervention Description
Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis
Intervention Type
Procedure
Intervention Name(s)
Prophylactic Pancreatic duct stenting
Other Intervention Name(s)
Rectal indomethacin 100 mg
Intervention Description
Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis
Primary Outcome Measure Information:
Title
To compare rectal indomethacin alone versus combined pancreatic duct stent and rectal indomethacin in prevention of post ERCP pancreatitis
Description
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.
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukti Pr Meher, MBBS, MD
Phone
9556694521
Ext
9178719869
Email
drmuktiprakash@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sugata N Biswas, MBBS, MD DM
Phone
9007073201
Email
biswassugatan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukti Pr Meher, MBBS, MD
Organizational Affiliation
Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology, MLN Medical college and SRN Hospital
City
Allahābād
State/Province
Uttar Pradesh
ZIP/Postal Code
211001
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mukti Pr Meher, MBBS, MD
Phone
9556694521
Ext
9178719869
Email
drmuktiprakash@gmail.com
Facility Name
Department of Gastroenterology and Hepatology
City
Allahābād
State/Province
Uttar Pradesh
ZIP/Postal Code
211001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mukti Pr Meher, MD
Phone
9556694521
Ext
9178719869
Email
drmuktiprakash@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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