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Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01620632
Collaborator
(none)
19
Enrollment
1
Location
79
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopy assisted ERCP

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.

Study Design

Study Type:
Observational
Actual Enrollment :
19 participants
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
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jul 2, 2018
Actual Study Completion Date :
Jul 2, 2018

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. patients with altered gastric anatomy who need an ERCP [approximately one week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Shands at the University of Florida Gainesville Florida United States 32610

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Peter V Draganov, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT01620632
    Other Study ID Numbers:
    • IRB201600462
    • 511-2011
    First Posted:
    Jun 15, 2012
    Last Update Posted:
    Jul 9, 2018
    Last Verified:
    Jul 1, 2018
    Keywords provided by University of Florida
    laparoscopy assisted ERCP
    altered gastric anatomy
    Additional relevant MeSH terms:
    Pancreatic Diseases
    Gallbladder Diseases

    Study Results

    No Results Posted as of Jul 9, 2018