Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

October 2, 2015 updated by: University of Florida

Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy

In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands at UF Endoscoppy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have a medical indication for ERCP and have altered gastric anatomy and are referred for the procedure as part of their standard medical care will be considered for this study.

Description

Inclusion Criteria:

  1. Subject is 18 years or older
  2. Subject has medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP)
  3. Subject has altered gastric anatomy
  4. Subject must be able to give informed consent.

Exclusion Criteria:

  1. Any contraindication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with overtube
  2. The subject is unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatobiliary disease
Patients who have altered gastric anatomy who need an ERCP with an overtube for evaluation of pancreatobiliary disease.
Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)
An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Papilla or Duct-enterostomy Was Reached
Time Frame: During procedure, up to 3 hours
During procedure, up to 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Cannulation of the Duct of Intent
Time Frame: During procedure, up to 3 hours
Deep cannulation of the bile/pancreatic duct was indicated in 12 of 13 ERCPs, one procedure was performed for stent removal only. This outcome was only relevant when deep cannulation was clinically indicated, therefore this outcome was determined out of 12 ERCPs.
During procedure, up to 3 hours
Successful Endoscopic Therapy
Time Frame: During procedure, up to 3 hours
During procedure, up to 3 hours
Total Procedure Time
Time Frame: During procedure, up to 3 hours
During procedure, up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pancreatobiliary disorders

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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