Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

Description

This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

Conditions

Post-ERCP Acute Pancreatitis

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Study Overview

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Study Details

Study overview

This research is being done to see if using oral tacrolimus before endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

A Randomized Trial Comparing Rectal Indomethacin Alone Versus a Combination of Rectal Indomethacin and Oral Tacrolimus for Post-ERCP Pancreatitis Prophylaxis

Rectal Indomethacin and Oral Tacrolimus Versus Combination to Prevent Post-ERCP Pancreatitis

Condition
Post-ERCP Acute Pancreatitis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Any patient who is undergoing endoscopic retrograde cholangiopancreatography (ERCP) at any of the participating centers, is at least 18 years old and provides informed consent can be included in the study.
  • * Unwillingness or inability to consent for the study.
  • * Pregnancy
  • * Breastfeeding mother
  • * Chronic calcific pancreatitis
  • * ERCP for biliary stent exchange or removal
  • * ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.
  • * Biliary intervention in a patient with pancreas divisum.
  • * Standard contraindications to tacrolimus or NSAID use.
  • * Current tacrolimus or immune modulator use.
  • * Chronic kidney disease with glomerular filtration rate (GFR) \< 30 or acute kidney injury.
  • * Absence of rectum.
  • * Acute pancreatitis within 30 days of ERCP.
  • * Pancreatic head malignancy.
  • * Sphincter of Oddi dysfunction (Type 3).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Venkata S. Akshintala, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2024-12