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Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

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ClinicalTrials.gov Identifier: NCT01620632
Recruitment Status : Recruiting
First Posted : June 15, 2012
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Biliary Disease Pancreas Disease 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
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Study Type : Observational
Estimated Enrollment : 100 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 : December 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort 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
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Primary Outcome Measures :
  1. patients with altered gastric anatomy who need an ERCP [ Time Frame: approximately one week ]

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01620632     History of Changes
Other Study ID Numbers: 511-2011
First Posted: June 15, 2012    Key Record Dates
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