SpHincterotomy for Acute Recurrent Pancreatitis

Completed · Not applicable · Has a placebo group

Conditions studied: Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed

In brief

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.

Key facts

Study ID

NCT03609944

Run by

Oregon Health and Science University

People needed

181

Starts

2018-09-27

Expected to finish

2025-08-31

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must consent to be in the study and must have signed and dated an approved consent form.
• >18 years
• 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
• At least one episode of acute pancreatitis within 24 months of enrollment
• Pancreas divisum confirmed by prior MRCP that is reviewed by an abdominal radiologist at the recruiting site.
• By physician assessment, there is no certain explanation for recurrent acute pancreatitis.
• 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

You may not qualify if…

• Prior minor papilla therapy (endoscopic or surgical)
• 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.
• Main pancreatic duct stricture*
• Presence of a structural etiology for acute pancreatitis, such as anomalous pancreatobiliary union, periampullary mass, or pancreatic mass lesion on imaging*
• Presence of a local complication from acute pancreatitis which requires pancreatogram
• Regular use of opioid medication for abdominal pain for the past three months
• Medication as the etiology for acute pancreatitis by physician assessment
• TWEAK score ≥ 4

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Cedars-Sinai — Los Angeles, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Saint Luke's Hospital System — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Rochester — Rochester, New York, United States
• The Ohio State University - Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Virginia Mason Hospital & Seattle Medical Center — Seattle, Washington, United States
• Health Sciences Centre — Winnipeg, Manitoba, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.