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COMPLETED NA

SpHincterotomy for Acute Recurrent Pancreatitis

NCT03609944 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE EUS
  • PROCEDURE ERCP with miES

Study Locations (20)

California

  • Keck Hospital of USC — Los Angeles
  • Cedars-Sinai — Los Angeles
  • UCSF Medical Center — San Francisco

Arkansas

  • University of Arkansas for Medical Sciences — Little Rock

Connecticut

  • Yale School of Medicine — New Haven

Georgia

  • Emory University Hospital — Atlanta

Illinois

  • Northwestern University — Chicago

Indiana

  • Indiana University — Indianapolis

Massachusetts

  • Beth Israel Deaconess Medical Center — Boston

Minnesota

  • University of Minnesota — Minneapolis

Trial Details

FieldValue
Enrollment Target 181 participants
Start Date 2018-09-27
Est. Completion 2025-08-31
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03609944

The ClinicalTrials.gov registry entry for NCT03609944 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 665 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Pancreatitis appearing as the primary indexed condition, and to 2 interventions — of which EUS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03609944 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Arkansas, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03609944 about?

NCT03609944 is a clinical study titled "SpHincterotomy for Acute Recurrent Pancreatitis". 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...

What is the current status of trial NCT03609944?

This trial is currently completed. It is a NA study. The enrollment target is 181 participants. The study started on 2018-09-27. Estimated completion is 2025-08-31.

What conditions does trial NCT03609944 study?

This clinical trial studies the following conditions: Pancreatitis, Pancreatitis, Acute, Pancreas Inflamed, Pancreas Divisum, Pancreatitis Idiopathic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03609944?

The interventions under investigation include: EUS (PROCEDURE), ERCP with miES (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03609944?

This trial is sponsored by Oregon Health and Science University, which has 665 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03609944 being conducted?

This trial has 20 study locations across Arkansas, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial