Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Completed

• Conditions: Steatohepatitis; Morbid Obesity

• Registration Number: NCT00512512
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-07
• Primary Completion: 2008-01
• Study Completion: 2009-06
• Status Verified: 2009-07
• Last Update Submitted: 2010-06-30
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States