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Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

This study is currently recruiting participants.
Verified November 2017 by University of Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620632
First Posted: June 15, 2012
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
  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 ]

Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01620632     History of Changes
Other Study ID Numbers: 511-2011
First Submitted: June 13, 2012
First Posted: June 15, 2012
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

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