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Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

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:
NCT01620632
First received: June 13, 2012
Last updated: October 21, 2014
Last verified: October 2014
History of Changes
  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:

MedlinePlus related topics: Anatomy
U.S. FDA Resources

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
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: 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: October 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 03, 2015