Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

NCT ID: NCT00512512

Last Updated: 2010-07-01

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

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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This research is being done to evaluate the ability to obtain a liver sample using upper endoscopy rather than through a laparoscopic procedure. The investigators hypothesize that the endoscopic transoral route is as effective as the laparoscopic route.

Detailed Description

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Conditions

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Steatohepatitis Morbid Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transoral Endoscopic Liver Biopsy

Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Any patient who meets criteria to undergo laparoscopic Roux-en Y Gastric Bypass (BMI\>40 or BMI\>35 with multiple medical co morbidities).
2. Age greater than 18 years.
3. Ability to complete all necessary components of study (gastric bypass surgery standard qualifications).

Exclusion Criteria

1. Inability to give informed consent
2. Women who are pregnant or in whom pregnancy status cannot be confirmed.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Johns Hopkins

Principal Investigators

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Michael A Schweitzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Steele K, Schweitzer MA, Lyn-Sue J, Kantsevoy SV. Flexible transgastric peritoneoscopy and liver biopsy: a feasibility study in human beings (with videos). Gastrointest Endosc. 2008 Jul;68(1):61-6. doi: 10.1016/j.gie.2007.09.040. Epub 2008 Mar 4.

Reference Type RESULT
PMID: 18308313 (View on PubMed)

Other Identifiers

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NA_00007226

Identifier Type: -

Identifier Source: org_study_id

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