Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Morbid Obesity Clinical Trial

Official title:

Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512512
• Other study ID #: NA_00007226
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: June 30, 2010
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Morbid Obesity
• Obesity, Morbid
• Steatohepatitis

Intervention

Procedure:
• Transoral Endoscopic Liver Biopsy
Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass

Locations

Country	Name	City	State
United States	Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation