N/A
N=148
SpHincterotomy for Acute Recurrent Pancreatitis
Pancreatitis · Pancreas Divisum · Pancreatitis, Acute · Pancreatitis Idiopathic · Pancreas Inflamed
Bottom Line
View on ClinicalTrials.gov: NCT03609944 ↗Enrolled (actual)
148
Serious AEs
64.9%
Results posted
Dec 2025
Primary outcome: Primary: Reduce the Risk of Subsequent Acute Pancreatitis Episodes by 33% — 32; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ERCP with miES (Procedure); EUS (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduce the Risk of Subsequent Acute Pancreatitis Episodes by 33% |
32; 26 | — |
| SECONDARY To Compare the Incidence Rate Ratio of Acute Pancreatitis Between Treatment Groups |
0.304; .246 | — |
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 Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03609944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.