Evaluation of Pancreatobiliary Disorders in Patients With Altered Gastric Anatomy

This study has been completed.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
First received: November 8, 2010
Last updated: October 2, 2015
Last verified: October 2015
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful Cannulation of the Duct of Intent [ Time Frame: During procedure, up to 3 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Total Procedure Time [ Time Frame: During procedure, up to 3 hours ] [ Designated as safety issue: No ]

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


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.

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

United States, Florida
Shands at UF Endoscoppy Center
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
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
Results First Received: September 2, 2015
Last Updated: October 2, 2015
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 25, 2015