Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2016 by University of Florida

Sponsor:

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT01620632

First received: June 13, 2012

Last updated: September 13, 2016

Last verified: September 2016

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 2016
Estimated Primary Completion Date:	December 2016 (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 (Adult, Senior)
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


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:	September 13, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016

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