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Hepatic Effects of Gastric Bypass Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Outcomes Research Consortium.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00701376
First received: June 18, 2008
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Liver Diseases
 Other: liver biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Long Term Hepatic Effects of Gastric Bypass Surgery

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • liver function [ Time Frame: 18 mos. post operative ] [ Designated as safety issue: No ]
    To assess the extent of long-term improvement in both liver function and histology in the morbidly obese after LGBS.

  • liver histology [ Time Frame: 18 mos. post operative ] [ Designated as safety issue: No ]
    To assess the extent of long-term improvement in both liver function and histology in the morbidly obese after LGBS.

  • change in non-invasive ICF measure clearance values [ Time Frame: 18 mos. post procedure ] [ Designated as safety issue: No ]
    To assess the correlation between the change in both a) non-invasive ICG measurement clearance values and b) standard biochemical tests of liver function and the change in the observed hepatic microscopic changes seen in liver biopsy specimens from before to after LGBS surgery.

  • change in liver function [ Time Frame: 18 mos. post procedure ] [ Designated as safety issue: No ]
    To assess the correlation between the change in both a) non-invasive ICG measurement clearance values and b) standard biochemical tests of liver function and the change in the observed hepatic microscopic changes seen in liver biopsy specimens from before to after LGBS surgery.

  • change in microscopic liver biopsy specimens [ Time Frame: 18 mos. post procedure ] [ Designated as safety issue: No ]
    To assess the correlation between the change in both a) non-invasive ICG measurement clearance values and b) standard biochemical tests of liver function and the change in the observed hepatic microscopic changes seen in liver biopsy specimens from before to after LGBS surgery.


Secondary Outcome Measures:
  • non-invasive measurement of ICG clearance and biochemical testing on diagnostic accuracy [ Time Frame: 18 mos. post procedure ] [ Designated as safety issue: No ]
    To compare the non-invasive measurement of ICG clearance and biochemical testing on diagnostic accuracy (including sensitivity, specificity, accuracy and positive and negative predictive value) of detecting histological liver disease both before and after LGBS. Of particular interest is determining whether non-invasive measurement of ICG clearance is sufficiently sensitive to detect occult liver dysfunction in morbidly obese patients in whom no specific clinical or biochemical evidence of liver dysfunction exists.


Estimated Enrollment: 100
Study Start Date: June 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
liver function
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
 Other: liver biopsy
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
Other Names:
  • liver
  • needle
  • biopsy

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701376

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44159
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Brian M. Parker, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Brian Parker, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00701376     History of Changes
Other Study ID Numbers: 07-877
Study First Received: June 18, 2008
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Gastric Bypass surgery
Hepatic disease
Hepatic function

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013