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Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00512512
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : July 1, 2010
Information provided by:

August 6, 2007
August 7, 2007
July 1, 2010
June 2007
January 2008   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00512512 on ClinicalTrials.gov Archive Site
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Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Morbid Obese patients who are already approved for gastric bypass surgery.
  • Steatohepatitis
  • Morbid Obesity
Procedure: Transoral Endoscopic Liver Biopsy
Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2009
January 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Michael Schweitzer, M.D., Johns Hopkins
Johns Hopkins University
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Principal Investigator: Michael A Schweitzer, M.D. Johns Hopkins University
Johns Hopkins University
July 2009