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
  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:


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
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:
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, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014