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Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass

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ClinicalTrials.gov Identifier: NCT00512512
Recruitment Status : Completed
First Posted : August 7, 2007
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:
Johns Hopkins University

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Steatohepatitis Morbid Obesity Procedure: Transoral Endoscopic Liver Biopsy

Study Design
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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transoral Endoscopic Liver Biopsy During Laparoscopic Gastric Bypass
Study Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy
U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    Procedure: Transoral Endoscopic Liver Biopsy
    Liver will be biopsied with transoral endoscope instead of the laparoscopic instruments during laparoscopic gastric bypass

Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Michael Schweitzer, M.D., Johns Hopkins
ClinicalTrials.gov Identifier: NCT00512512     History of Changes
Other Study ID Numbers: NA_00007226
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: July 2009

Keywords provided by Johns Hopkins University:
transoral
transluminal
endoscopic
 laparoscopic
liver
biopsy

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