Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00512512

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Steatohepatitis Morbid Obesity	Procedure: Transoral Endoscopic Liver Biopsy

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jun 1, 2009

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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