N/A
N=106
Hepatic Effects of Gastric Bypass Surgery
Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00701376 ↗Enrolled (actual)
106
Serious AEs
1.9%
Results posted
Jun 2020
Primary outcome: Primary: Aspartate Transaminase (AST) Change — -6.32 U/L — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- liver biopsy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aspartate Transaminase (AST) Change |
-6.32 | 0.03 sig |
| PRIMARY Alanine Transaminase (ALT) Change |
-7.56 | 0.08 |
| PRIMARY Alkaline Phosphate (ALK) |
5.84 | 0.14 |
| PRIMARY Total Bilirubin |
0.01 | — |
| PRIMARY Albumin |
-0.2 | <0.001 sig |
| PRIMARY Prothrombin Time (PT) |
-0.23 | 0.10 |
| PRIMARY Partial Thromboplastin Time (PTT) |
-1.72 | 0.21 |
| PRIMARY Indocyanine Green (ICG) K Value |
0.01 | — |
| PRIMARY Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) |
11; 3; 1; 0 | 0.002 sig |
| PRIMARY Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation |
10; 4; 1; 0 | 0.04 sig |
| PRIMARY Fibrosis |
6; 0; 0; 1; 5; 2 | 0.005 sig |
| PRIMARY Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon |
12; 3; 0 | 0.001 sig |
| SECONDARY Diagnostic Accuracy-AST |
72 | — |
| SECONDARY Diagnostic Accuracy-ALT |
76 | — |
| SECONDARY Diagnostic Accuracy-ALK |
65 | — |
| SECONDARY Diagnostic Accuracy-total Bilirubin |
53 | — |
| SECONDARY Diagnostic Accuracy-PT |
54 | — |
| SECONDARY Diagnostic Accuracy-PTT |
46 | — |
| SECONDARY Diagnostic Accuracy-ICG k Value |
53 | — |
| SECONDARY Diagnostic Accuracy-albumin |
55 | — |
| SECONDARY Diagnostic Accuracy-multiple Factor |
0.82 | — |
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.
Eligibility Criteria
Inclusion Criteria
- BMI > 40.
- Documented failed non-surgical treatment for morbid obesity.
- Ability to undergo long-term follow-up after LGBS.
Exclusion Criteria
- BMI 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.
Data sourced from ClinicalTrials.gov (NCT00701376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.