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Can a simple scope procedure stop recurrent pancreatitis? SHARP trial results are in

NCT ID NCT03609944

Prevention Sponsor: Oregon Health and Science University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a procedure called ERCP with sphincterotomy can lower the risk of repeat pancreatitis attacks in people with pancreas divisum, a condition where the pancreas ducts don't join normally. 181 adults who had at least two pancreatitis episodes were randomly assigned to get the real procedure or a sham procedure. Researchers tracked participants for up to 48 months to see if the procedure reduced the number of future pancreatitis attacks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

181 people

The number who actually took part.

Started

Sep 2018

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute pancreatitis chronic pancreatitis idiopathic chronic pancreatitis Pancreas Divisum pancreatitis recurrent acute pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreas divisum Pancreas inflamed Pancreatitis Pancreatitis idiopathic Pancreatitis, acute

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Cedars-Sinai

    Los Angeles, California, 90048, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29407, United States

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97202, United States

  • Saint Luke's Hospital System

    Kansas City, Missouri, 64111, United States

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UCSF Medical Center

    San Francisco, California, 94143, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester

    Rochester, New York, 14627, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Virginia Mason Hospital & Seattle Medical Center

    Seattle, Washington, 98101, United States

  • Yale School of Medicine

    New Haven, Connecticut, 06520, United States

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