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Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238341
First Posted: November 10, 2010
Last Update Posted: October 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  Purpose
In patients, who have altered gastric anatomy and pancreatobiliary disease, the use of an endoscopic overtube to facilitate an Endoscopic Retrograde Cholangiopancreatography (ERCP).

Condition Intervention
Pancreatobiliary Disease Altered Gastric Anatomy Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of Clinical Utility of Endoscopic Retrograde Cholangiopancreatography (ERCP) With Overtube in Patients With Altered Gastric Anatomy

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Papilla or Duct-enterostomy Was Reached [ Time Frame: During procedure, up to 3 hours ]

Secondary Outcome Measures:
  • 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.

  • Successful Endoscopic Therapy [ Time Frame: During procedure, up to 3 hours ]
  • Total Procedure Time [ Time Frame: During procedure, up to 3 hours ]

Enrollment: 7
Study Start Date: June 2007
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238341


Locations
United States, Florida
Shands at UF Endoscoppy Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238341     History of Changes
Other Study ID Numbers: Pancreatobiliary disorders
First Submitted: November 8, 2010
First Posted: November 10, 2010
Results First Submitted: September 2, 2015
Results First Posted: October 5, 2015
Last Update Posted: October 23, 2015
Last Verified: October 2015

Keywords provided by University of Florida:
Pancreatobiliary disease in patients with altered gastric anatomy.