Laparoscopy-assisted ERCP in Patients With Altered Gastric Anatome

NCT ID: NCT01620632

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2018-07-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Biliary Disease Pancreas Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Altered gastric anatomy

Patients who have an altered gastric who need an ERCP

Laparoscopy assisted ERCP

Intervention Type PROCEDURE

Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.

Interventions

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Laparoscopy assisted ERCP

Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic Retrograde Cholangiopancreatography (ERCP) Roux-en-Y gastric bypass surgery Laparoscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter V Draganov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Shands at the University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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511-2011

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201600462

Identifier Type: -

Identifier Source: org_study_id

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