RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2023-01-18
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05252754

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Unwillingness or inability to consent for the study.
  2. * Pregnancy
  3. * Breastfeeding mother
  4. * Chronic calcific pancreatitis
  5. * ERCP for biliary stent exchange or removal
  6. * ERCP in a patient with prior biliary sphincterotomy, but without anticipated pancreatogram.
  7. * Biliary intervention in a patient with pancreas divisum.
  8. * Standard contraindications to tacrolimus or NSAID use.
  9. * Current tacrolimus or immune modulator use.
  10. * Chronic kidney disease with glomerular filtration rate (GFR) \< 30 or acute kidney injury.
  11. * Absence of rectum.
  12. * Acute pancreatitis within 30 days of ERCP.
  13. * Pancreatic head malignancy.
  14. * Sphincter of Oddi dysfunction (Type 3).

Contacts and Locations

Study Contact

Venkata S. Akshintala, M.D.
CONTACT
+1 (410) 614-6708
vakshin1@jhmi.edu

Principal Investigator

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

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-18
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-01-18
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Post-ERCP Acute Pancreatitis