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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

August 6, 2007
June 30, 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
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
Not Provided
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. Epub 2008 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00512512
NA_00007226
No
Michael Schweitzer, M.D., Johns Hopkins
Johns Hopkins University
Not Provided
Principal Investigator: Michael A Schweitzer, M.D. Johns Hopkins University
Johns Hopkins University
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP