Status:
COMPLETED
Hepatic Effects of Gastric Bypass Surgery
Lead Sponsor:
The Cleveland Clinic
Conditions:
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat deposits in the liver, resulting in inflammation and scarring of the liver over time, which reduces liver f...
Detailed Description
Before or on the day of surgery liver function will be determined using the DDG-2001 Analyzer. This monitor is able to detect the concentration of a dye called indocyanine green dye (ICG) when present...
Eligibility Criteria
Inclusion
- BMI \> 40.
- Documented failed non-surgical treatment for morbid obesity.
- Ability to undergo long-term follow-up after LGBS.
Exclusion
- BMI \< 40.
- Subject age \< 18 years.
- Inability to undergo long-term follow-up after LGBS (living distance \> 300 miles).
- Patients with known ESLD.
- Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy.
- Patients with known iodine sensitivity or allergy.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00701376
Start Date
June 1 2008
End Date
September 1 2014
Last Update
June 19 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44159