Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

This study has been completed.

Sponsor:

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT00512512

First received: August 6, 2007

Last updated: June 30, 2010

Last verified: July 2009

History of Changes

Purpose

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	Intervention
Steatohepatitis Morbid Obesity	Procedure: Transoral Endoscopic Liver Biopsy


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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:


Enrollment:	4
Study Start Date:	June 2007
Study Completion Date:	June 2009
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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
Sampling Method:	Non-Probability Sample

Study Population

Morbid Obese patients who are already approved for gastric bypass surgery.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Maryland
Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

Investigators


Principal Investigator:	Michael A Schweitzer, M.D.	Johns Hopkins University

More Information

Publications:

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.


Responsible Party:	Michael Schweitzer, M.D., Johns Hopkins
ClinicalTrials.gov Identifier:	NCT00512512 History of Changes
Other Study ID Numbers:	NA_00007226
Study First Received:	August 6, 2007
Last Updated:	June 30, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:


transoral transluminal endoscopic	laparoscopic liver biopsy

ClinicalTrials.gov processed this record on March 01, 2015

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