SpHincterotomy for Acute Recurrent Pancreatitis (SHARP)

November 14, 2023 updated by: Gregory Cote, Oregon Health and Science University

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gregory Cote, MD, MS
  • Phone Number: 503-494-5255
  • Email: coteg@ohsu.edu

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Dana Moffatt, MD
  • Netherlands
      • Nijmegen, Netherlands
        • Withdrawn
        • Radboud University Medical Center
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences
        • Contact:
        • Principal Investigator:
          • Sumant Inamdar, MBBS, MPH
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai
        • Contact:
        • Principal Investigator:
          • Srinivas Gaddam, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Hospital of USC
        • Contact:
        • Principal Investigator:
          • James Buxbaum
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center
        • Contact:
        • Principal Investigator:
          • Sun-Chuan Dai, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Terminated
        • Yale School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Field F. Willingham, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Rajesh Keswani, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Evan Fogel, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Terminated
        • Beth Israel Deaconess Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • Martin Freeman, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital System
        • Contact:
        • Principal Investigator:
          • Srinivas Jonnalagadda, MD
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Terminated
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Rochester, New York, United States, 14627
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Truptesh Kothari, MD, MS
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University - Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Darwin Conwell, MD
    • Oregon
      • Portland, Oregon, United States, 97202
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Gregory Cote, MD, MS
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Dhiraj Yadav, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Badih J Elmunzer, MD
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
        • Principal Investigator:
          • Prashant Kedia, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Seattle, Washington, United States, 98101
        • Terminated
        • Virginia Mason Hospital & Seattle Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient must consent to be in the study and must have signed and dated an approved consent form.
  2. >18 years

  3. Two or more episodes of acute pancreatitis, with each episode meeting two of the following 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 than the upper limit of normal
    • characteristic findings of acute pancreatitis on CECT, MRI or transabdominal ultrasonography
  4. At least one episode of acute pancreatitis within 24 months of enrollment
  5. Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site.
  6. By physician assessment, there is no certain explanation for recurrent acute pancreatitis.
  7. Subjects must be able to fully understand and participate in all aspects of the study, including completion of questionnaires and telephone interviews, in the opinion of the clinical investigator

Exclusion Criteria:

  1. Prior minor papilla therapy (endoscopic or surgical)
  2. Calcific chronic pancreatitis, defined as parenchymal or ductal calcifications identified on computed tomography or magnetic resonance imaging scan that is reviewed by an expert radiologist at the recruiting site.
  3. Main pancreatic duct stricture*
  4. Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging*
  5. Presence of a local complication from acute pancreatitis which requires pancreatogram
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: EUS + Sham
Subjects randomized to EUS + sham will undergo a diagnostic endoscopic ultrasound (EUS) under sedation. The physician investigator will not make any attempts to achieve minor papilla cannulation, but photo document the minor papilla using a duodenoscope. Diluted dye will be injected into the duodenum. A small caliber prophylactic pancreatic duct stent will be deposited into the duodenal lumen. These maneuvers are performed to minimize the risk of unmasking.
Procedure: EUS
Endoscopic ultrasound
Experimental: EUS + ERCP with miES
Subjects randomized to EUS + ERCP with miES will undergo the procedure at the same time as endoscopic ultrasound (EUS), under sedation. Indomethacin (100 mg) will be administered rectally at the onset of the ERCP procedure in patients with no known allergy to indomethacin. The techniques used to perform the endoscopic retrograde cholangiopancreatography (ERCP)with miES (minor papilla endoscopic sphincterotomy) will be left to the discretion of the study endoscopist. The extent of sphincterotomy will be per the discretion of the treating endoscopist. Unless methylene blue (or similar chromoendoscopy agent such as indigo carmine) has already been used to facilitate minor papilla cannulation, diluted dye will be injected into the duodenum.
Procedure: EUS
Endoscopic ultrasound
Procedure: ERCP with miES
Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce the risk of subsequent acute pancreatitis episodes by 33%
Time Frame: This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.
To test this aim, compare the incidence of acute pancreatitis > 30 days after treatment allocation as the primary outcome measure, using the next attack of acute pancreatitis as a time-to-event outcome.
This is a time-to-event outcome that is assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the incidence rate ratio of acute pancreatitis between treatment groups
Time Frame: Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.
All randomized subjects will be followed longitudinally until study completion (minimum follow-up of six months, maximum follow-up of 48 months), even if acute pancreatitis occurs during follow-up. A secondary benefit of miES may be a reduction in acute pancreatitis frequency, defined as the incidence rate (episodes/time pre- and post-randomization). Since baseline incidence rate is a probable predictor of post-randomization incidence rate, the investigators will compare the incidence rate ratios between the two arms, keeping person-time equal between the pre/post periods.
Incidence rate will be assessed starting 30 days after treatment through a maximum follow-up of 48 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Study Chair: Gregory A Cote, MD, MS, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 31, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1922
  • U01DK116743 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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