Overview

This trial is active, not recruiting.

Condition liver diseases
Treatment liver biopsy
Sponsor Outcomes Research Consortium
Start date June 2008
End date June 2011
Trial size 100 participants
Trial identifier NCT00701376, 07-877

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 function. However, many of these patients are unaware that their liver is damaged. There is currently no consensus regarding what the long-term effects of gastric bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will determine the long-term effects on the liver after this type of surgical procedure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Other)
Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss
liver biopsy liver
Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss

Primary Outcomes

Measure
liver function
time frame: 18 mos. post operative
liver histology
time frame: 18 mos. post operative
change in non-invasive ICF measure clearance values
time frame: 18 mos. post procedure
change in liver function
time frame: 18 mos. post procedure
change in microscopic liver biopsy specimens
time frame: 18 mos. post procedure

Secondary Outcomes

Measure
non-invasive measurement of ICG clearance and biochemical testing on diagnostic accuracy
time frame: 18 mos. post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. BMI > 40. 2. Documented failed non-surgical treatment for morbid obesity. 3. Ability to undergo long-term follow-up after LGBS. Exclusion Criteria: 1. BMI < 40. 2. Subject age < 18 years. 3. Inability to undergo long-term follow-up after LGBS (living distance > 300 miles). 4. Patients with known ESLD. 5. Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy. 6. Patients with known iodine sensitivity or allergy.

Additional Information

Official title Long Term Hepatic Effects of Gastric Bypass Surgery
Principal investigator Brian M. Parker, MD
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 in the blood stream. A dose of 0.5 mg/kg of ICG will be injected into an IV in the arm. Over approximately fifteen minutes the DDG-2001 Analyzer will determine how quickly the liver removes the dye ICG from the blood stream. This value represents how well the liver is functioning. Blood samples are drawn before injection of ICG to measure liver function using standard liver function tests. This same routine for injecting ICG and obtaining blood for routine liver function tests will happen one more time, after surgery, once the subject has lost a significant amount of the original weight (60% of excess weight). This amount of weight loss typically occurs between 12 to 18 months after gastric bypass surgery. This second ICG measurement will occur during an outpatient follow-up visit to CCF. A biopsy will be taken from the liver during surgery. A second biopsy taken after the 60% weight loss will be compared to determine the effect of this surgery on the liver.
Trial information was received from ClinicalTrials.gov and was last updated in February 2011.
Information provided to ClinicalTrials.gov by Outcomes Research Consortium.