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Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

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.
 
ClinicalTrials.gov Identifier: NCT01238341
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : October 5, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

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

Condition or disease Intervention/treatment
Pancreatobiliary Disease Altered Gastric Anatomy Procedure: Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Design
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Study Type : Observational
Actual Enrollment : 7 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Endoscopy

Groups and Cohorts
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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


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

Secondary Outcome Measures :
  1. 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.

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Florida
Shands at UF Endoscoppy Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Peter Draganov, MD University of Florida
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01238341    
Other Study ID Numbers: Pancreatobiliary disorders
First Posted: November 10, 2010    Key Record Dates
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.