SpHincterotomy for Acute Recurrent Pancreatitis

Last updated: November 16, 2024
Sponsor: Oregon Health and Science University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pancreatitis

Primary Biliary Cholangitis

Treatment

EUS

ERCP with miES

Clinical Study ID

NCT03609944
1922
U01DK116743
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if a procedure called Endoscopic Retrograde CholangioPancreatography (ERCP) with sphincterotomy reduces the risk of pancreatitis or the number of recurrent pancreatitis episodes in patients with pancreas divisum. ERCP with sphincterotomy is a procedure where doctors used a combination of x-rays and an endoscope (a long flexible lighted tube) to find the opening of the duct where fluid drains out of the pancreas. People who have been diagnosed with pancreas divisum, have had at least two episodes of pancreatitis, and are candidates for the ERCP with sphincterotomy procedure may be eligible to participate. Participants will be will be randomly assigned to either have the ERCP with sphincterotomy procedure, or to have a "sham" procedure. Participants will have follow up visits 30 days after the procedure, 6 months after the procedure, and continuing every 6 months until a maximum follow-up period of 48 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient must consent to be in the study and must have signed and dated an approvedconsent form.

  2. >18 years

  3. Two or more episodes of acute pancreatitis, with each episode meeting two of thefollowing three criteria:

  • abdominal pain consistent with acute pancreatitis (acute onset of a persistent,severe, epigastric pain often radiating to the back)

  • serum lipase activity (or amylase activity) at least three times greater thanthe upper limit of normal

  • characteristic findings of acute pancreatitis on CECT, MRI or transabdominalultrasonography

  1. At least one episode of acute pancreatitis within 24 months of enrollment

  2. Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominalradiologist at the recruiting site.

  3. By physician assessment, there is no certain explanation for recurrent acutepancreatitis.

  4. Subjects must be able to fully understand and participate in all aspects of thestudy, including completion of questionnaires and telephone interviews, in theopinion of the clinical investigator

Exclusion

Exclusion Criteria:

  1. Prior minor papilla therapy (endoscopic or surgical)

  2. Calcific chronic pancreatitis, defined as parenchymal or ductal calcificationsidentified on computed tomography or magnetic resonance imaging scan that isreviewed by an expert radiologist at the recruiting site.

  3. Main pancreatic duct stricture*

  4. Presence of a structural etiology for acute pancreatitis, such as anomalouspancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging*

  5. Presence of a local complication from acute pancreatitis which requirespancreatogram

  6. Regular use of opioid medication for abdominal pain for the past three months

  7. Medication as the etiology for acute pancreatitis by physician assessment

  8. TWEAK score ≥ 4

Study Design

Total Participants: 181
Treatment Group(s): 2
Primary Treatment: EUS
Phase:
Study Start date:
September 27, 2018
Estimated Completion Date:
August 31, 2025

Study Description

This is a sham-controlled, single blinded with a blinded outcome assessment, multi-center, randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis (RAP) with pancreas divisum. ERCP with miES is often offered in clinical practice to patients with RAP, pancreas divisum, and no other clear risk factors for their acute pancreatitis episodes. The hypothesis is that obstruction at the level of the minor papilla is one cause of RAP in pancreas divisum; miES will relieve the obstruction, thereby reducing the risk of a recurrent attack(s) of acute pancreatitis. The trial requires a total sample size of approximately 234 subjects, and a planned enrollment period of approximately 3.5 years with total planned study duration of 5 years (minimum follow-up of 6 months, maximum follow-up of 48 months).

Connect with a study center

  • Health Sciences Centre

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Cedars-Sinai

    Los Angeles, California 90048
    United States

    Site Not Available

  • Keck Hospital of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCSF Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Yale School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Saint Luke's Hospital System

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14627
    United States

    Site Not Available

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97202
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Virginia Mason Hospital & Seattle Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

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