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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
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 Obesity
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:
    Procedure: Transoral Endoscopic Liver Biopsy
    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:

  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.
  Contacts and Locations
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:

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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Fatty Liver
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013