NCT05857514

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

12 months

First QC Date

April 9, 2023

Last Update Submit

June 25, 2023

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Rectal indomethacin

ACTIVE COMPARATOR
Drug: Rectal Indomethacin

Pancreatic duct stent and rectal indomethacin

ACTIVE COMPARATOR
Procedure: Prophylactic Pancreatic duct stenting

Interventions

Rectal IndomethacinDRUG

Prophylactic Rectal indomethacin 100mg for prevention of post ERCP pancreatitis

Rectal indomethacin
Prophylactic Pancreatic duct stentingPROCEDURE

Prophylactic pancreatic duct stenting with rectal indomethacin 100 mg for prevention of post-ERCP pancreatitis

Also known as: Rectal indomethacin 100 mg
Pancreatic duct stent and rectal indomethacin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • pancreatogram
  • Acinarization (Contrast injection to tail of pancreas
  • Normal serum bilirubin
  • Guidewire to the tail of pancreas or secondary branches

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Allahābād, Uttar Pradesh, 211001, India

NOT YET RECRUITING

Department of Gastroenterology and Hepatology

Allahābād, Uttar Pradesh, 211001, India

RECRUITING

Study Officials

  • Mukti Pr Meher, MBBS, MD

    Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mukti Pr Meher, MBBS, MD

CONTACT

9556694521drmuktiprakash@gmail.com

Sugata N Biswas, MBBS, MD DM

CONTACT

9007073201biswassugatan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 9, 2023

First Posted

May 12, 2023

Study Start

May 10, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(2)