Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

This study is currently recruiting participants.

Verified by Johns Hopkins University, April 2008

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00512512

Purpose

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

Condition	Intervention
Steatohepatitis Morbid Obesity	Procedure: Transoral Endoscopic Liver Biopsy

MedlinePlus related topics: Endoscopy Obesity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

Further study details as provided by Johns Hopkins University:

Study Start Date:	June 2007
Estimated Study Completion Date:	September 2007

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Exclusion Criteria:

Inability to give informed consent
Women who are pregnant or in whom pregnancy status cannot be confirmed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512512

Contacts

Contact: Michael A Schweitzer, M.D.

410-550-5900

mschwei7@jhmi.edu

Locations

United States, Maryland
Hopkins Bayview Medical Center	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michael A Schweitzer, MD 410-550-3345 mschwei7@jhmi.edu
Principal Investigator: Michael A Schweitzer, M.D.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Michael A Schweitzer, M.D.

Johns Hopkins University

More Information

Study ID Numbers:	NA_00007226
Study First Received:	August 6, 2007
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00512512
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

transoral
transluminal
endoscopic

laparoscopic
liver
biopsy

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 15, 2009