Hepatic Effects of Gastric Bypass Surgery

NCT00701376 | Completed Results

• 1 other identifier: 07-877
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Diseases

Keywords

Gastric Bypass surgery; Hepatic disease; Hepatic function

Outcome Measures

Primary Outcomes (12)

• Aspartate Transaminase (AST) Change

  To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure

• Alanine Transaminase (ALT) Change

  To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure

• Alkaline Phosphate (ALK)

  To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure

• Total Bilirubin

  To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure

• Albumin

  To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

• Prothrombin Time (PT)

  To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

• Partial Thromboplastin Time (PTT)

  To measure the change of PTT from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

• Indocyanine Green (ICG) K Value

  To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure). ICG-k value is the slope of the decay curve of the serum ICG clearance graph, which is used to assess the liver function as it represents the rate of disappearance of ICG from blood as the liver exclusively distracts it. The lower k value means a lower rate of ICG clearance, indicating a worse liver function.

  from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)

• Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis)

  To compare the distribution of NAS steatosis stage from before surgery to when patients lost 60% of their preoperative excess weight or weight loss had plateaued. The NAFLD activity score (NAS) from the NASH clinical Clinic Research Network is the unweighted sum of scores for steatosis, lobular inflammation, and ballooning hepatocyte degeneration, and ranges from zero to eight points. The histological reporting for grading steatosis was based on a scale of 0 to 3, with 0 being no steatosis (\<5%), 1 being mild steatosis (involving 5-33% of the biopsy specimen), 2 being moderate steatosis (involving 34-66% of the specimen), and 3 being severe (involving \>66%).

  when patients lost 60% of their preoperative excess weight or weight loss had plateaued.

• Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation

  Lobular inflammation was similarly scored by number of foci per 200× magnification field (0 no foci: 1 \< 2 foci: 2, 2-4 foci; 3, \>4 foci) on biopsy specimen under microscope. This outcome was compared on its distribution before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued.

  when patients lost 60% of their preoperative excess weight or weight loss had plateaued.

• Fibrosis

  Fibrosis was measured from before surgery to after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued through biopsies

  after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued

• Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon

  Ballooning hepatocyte degeneration was scored as 0 (absent), 1 (few, difficult to identify), 2 (many, easily identified). This was to assess the change in the distribution of NAS hepatocyte ballon between before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued

  once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery

Secondary Outcomes (9)

• Diagnostic Accuracy-AST

  before RYGB surgery

• Diagnostic Accuracy-ALT

  before RYGB surgery

• Diagnostic Accuracy-ALK

  before RYGB surgery

• Diagnostic Accuracy-total Bilirubin

  before RYGB surgery

• Diagnostic Accuracy-PT

  before RYGB surgery

Study Arms (1)

liver function

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

Other: liver biopsy

Interventions

liver biopsy 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

Also known as: liver, needle, biopsy

liver function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 40.
• Documented failed non-surgical treatment for morbid obesity.
• Ability to undergo long-term follow-up after LGBS.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44159, United States

Location

MeSH Terms

Conditions

Liver Diseases; Digestive System Diseases

Interventions

Liver Extracts; Needles; Biopsy

Intervention Hierarchy (Ancestors)

Tissue Extracts; Complex Mixtures; Equipment and Supplies; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Brian Parker, MD
• Organization: Cleveland Clinic

parkerb1@ccf.org

216-444-9950

Study Officials

• Brian M. Parker, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 19, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-06

Locations

US (1)