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Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01238341
First received: November 8, 2010
Last updated: October 21, 2014
Last verified: October 2014
  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:
  • Use of overtube for an Endoscopic Retrograde Cholangiopancreatography (ERCP) in patients with altered gastric anatomy and pancreatobiliary disease. [ Time Frame: Approximately 2-3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238341

Contacts
Contact: Peter Draganov, MD 352-273-9400 peter.draganov@medicine.ufl.edu

Locations
United States, Florida
Shands at UF Endoscoppy Center Recruiting
Gainesville, Florida, United States, 32608
Contact: Peter Draganov, MD    352-273-9400    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter Draganov, MD         
Sub-Investigator: Mihir Wagh, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter Draganov, MD University of Florida
  More Information

No publications provided by University of Florida

Additional 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
Study First Received: November 8, 2010
Last Updated: October 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 27, 2014