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SpHincterotomy for Acute Recurrent Pancreatitis

NCT03609944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2025-12-30

Study results available
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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.

Conditions

  • Pancreatitis
  • Pancreas Divisum
  • Pancreatitis, Acute
  • Pancreatitis Idiopathic
  • Pancreas Inflamed

Interventions

PROCEDURE

ERCP with miES

Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy

PROCEDURE

EUS

Endoscopic ultrasound

Sponsors & Collaborators

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

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Gregory A Cote, MD, MS · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-27
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609944 on ClinicalTrials.gov