Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

This study is currently recruiting participants.
Verified April 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01620632
First received: June 13, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of this research study is to collect data on the technical aspects of Lasparoscopy-assisted ERCP and patient outcomes to help guide future medical care of patients with Roux-en-Y gastric bypass surgery.


Condition Intervention
Biliary Disease
Pancreas Disease
Procedure: Laparoscopy assisted ERCP

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Clinical Utility of Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatomy

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • patients with altered gastric anatomy who need an ERCP [ Time Frame: approximately one week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Altered gastric anatomy
Patients who have an altered gastric who need an ERCP
Procedure: Laparoscopy assisted ERCP
Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.
Other Names:
  • Endoscopic Retrograde Cholangiopancreatography (ERCP)
  • Roux-en-Y gastric bypass surgery
  • Laparoscopy

Detailed Description:

Patients would have had a Roux-en-Y gastric bypass in the past that had altered their gastric anatomy. Now they have developed bilary and/or pancreatic problems that require and ERCP. With their altered gastric anatomy a standard ERCP would not be possible. Thus they are scheduled for a Laparoscopy-assisted ERCP.

  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

Those patients who have altered gastric anatomy that require a laparoscopy assisted ERCP

Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Altered gastric anatomy
  • Scheduled to undergo laparoscopy-assisted ERCP

Exclusion Criteria:

  • Any contraindications to performing endoscopy
  • Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
  • The subject is unable/unwilling to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620632

Locations
United States, Florida
Shands at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Peter V Draganov, MD    352-273-9400    peter.draganov@medicine.ufl.edu   
Principal Investigator: Peter V Draganov, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter V Draganov, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01620632     History of Changes
Other Study ID Numbers: 511-2011
Study First Received: June 13, 2012
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
laparoscopy assisted ERCP
altered gastric anatomy

Additional relevant MeSH terms:
Gallbladder Diseases
Pancreatic Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014