Liver Diseases
Conditions
Keywords
Gastric Bypass surgery, Hepatic disease, Hepatic function
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.
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.
Interventions
OTHERliver 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
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon | once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery | 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 |
| Alkaline Phosphate (ALK) | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure | 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 |
| Total Bilirubin | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure | 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) |
| Albumin | 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) | 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) |
| Prothrombin Time (PT) | 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) | 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) |
| Partial Thromboplastin Time (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) | 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) |
| Indocyanine Green (ICG) K Value | 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) | 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. |
| Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) | when patients lost 60% of their preoperative excess weight or weight loss had plateaued. | 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%). |
| Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation | when patients lost 60% of their preoperative excess weight or weight loss had plateaued. | 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. |
| Fibrosis | after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued | 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 |
| Aspartate Transaminase (AST) Change | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure | 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) |
| Alanine Transaminase (ALT) Change | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy-ALT | before RYGB surgery | ALT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0. |
| Diagnostic Accuracy-ALK | before RYGB surgery | ALK was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0. |
| Diagnostic Accuracy-total Bilirubin | before RYGB surgery | The total bilirubin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0. |
| Diagnostic Accuracy-PT | before RYGB surgery | PT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
| Diagnostic Accuracy-PTT | before RYGB surgery | PTT (Partial Thromboplastin Time) was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
| Diagnostic Accuracy-ICG k Value | before RYGB surgery | ICG k value was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
| Diagnostic Accuracy-albumin | before RYGB surgery | Albumin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
| Diagnostic Accuracy-multiple Factor | before RYGB surgery | We also built a multivariable model using all preoperative liver function tests and ICG k clearance values to predict NASH (nonalcoholic steatohepatitis) from pre-RYGB values. AUC was used to assess the prediction performance of those multiple factors. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 95% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
| Diagnostic Accuracy-AST | before RYGB surgery | AST was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Roux-en-Y Gastric Bypass (RYGB) Before the treatment of RYGB surgery, eligible patients had preoperative liver function assessment including biochemical testing: AST, ALT, ALK, total bilirubin, albumin, and prothrombin (PT). During RYGB, a core liver biopsy was conducted. Serum lipid profiles and HbA1c values were medially optimized. Patients were asked to refrain from alcohol use for several preoperative days and discontinue hepatotoxic medications. Once patients lost 60% of their preoperative excess weight or weight loss had plateaued after RYGB surgery, they were reassessed on liver function(same as preoperative) and histology. Patients who had stable weight loss and were found to have clinically important liver damage as determined by liver biopsy at the time of RYGB were offered with repeat percutaneous ultrasound-guided liver biopsies after RYGB. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Roux-en-Y Gastric Bypass (RYGB) |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11 |
| Body Mass Index (BMI) | 48 kg/m^2 STANDARD_DEVIATION 8 |
| Duration of Obesity | 26 years STANDARD_DEVIATION 12 |
| Obesity Level Morbid Obesity | 93 Participants |
| Obesity Level Other | 2 Participants |
| Obesity Level Severe Obesity | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 2 / 106 |
Outcome results
Primary
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)
Time frame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Population: 84 patients did not have ALT measured
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Alanine Transaminase (ALT) Change | -7.56 U/L |
p-value: 0.0899.8% CI: [-22, 6.83]Wilcoxon (Mann-Whitney)
Primary
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)
Time frame: 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)
Population: Only 25 patients had their postoperative measurements taken.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Albumin | -0.2 g/dL |
p-value: <0.00199.8% CI: [-0.38, -0.02]paired t-test
Primary
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
Time frame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Alkaline Phosphate (ALK) | 5.84 U/L |
p-value: 0.1499.8% CI: [-7.55, 19.2]paired t-test
Primary
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)
Time frame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Population: 84 patients did not have AST measured after the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Aspartate Transaminase (AST) Change | -6.32 U/L |
p-value: 0.0399.8% CI: [-15.6, 2.94]paired t-test
Primary
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
Time frame: after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
Population: Only 15 patients had repeat liver biopsies
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 1C - Portal/periportal | 5 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 2 - Perisinusoidal and portal/periportal | 2 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | None | 6 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | Perisinusoidal or periportal | 0 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 1A - Mild, zone 3, perisinusoidal | 0 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 1B - Moderate, zone 3, perisinusoidal | 1 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 3 - Bridging fibrosis | 1 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Fibrosis | 4 - Cirrhosis | 0 Participants |
p-value: 0.005Wilcoxon signed-rank test
Primary
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.
Time frame: 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)
Population: Only 19 patients had their post-surgery ICG K measurement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Indocyanine Green (ICG) K Value | 0.01 K(ICG) Value |
Primary
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
Time frame: once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
Population: Only 15 patients had repeat liver biopsies
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon | Absent | 12 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon | Few Balloon Cells | 3 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon | Many cells / prominent ballooning | 0 Participants |
p-value: 0.001Wilcoxon signed-rank test
Primary
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.
Time frame: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Population: Only 15 people had agreed to have repeat liver biopsies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation | No foci | 10 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation | < 2 foci / 200× | 4 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation | 2-4 foci / 200× | 1 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation | > 4 foci / 200× | 0 Participants |
p-value: 0.04Wilcoxon signed-rank test
Primary
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%).
Time frame: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Population: The outcome shows the distribution result of NAS steatosis of patients after the surgery. Only 15 people had agreed to have repeat liver biopsies.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) | <5% | 11 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) | 5-33% | 3 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) | 34-66% | 1 Participants |
| Roux-en-Y Gastric Bypass (RYGB) | Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) | >66% | 0 Participants |
p-value: 0.002Wilcoxon signed-rank test
Primary
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)
Time frame: 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)
Population: Only 6 patients had their PTT measured after the surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Partial Thromboplastin Time (PTT) | -1.72 second |
p-value: 0.2199.8% CI: [-8.68, 5.25]paired t-test
Primary
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)
Time frame: 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)
Population: Only 25 patients had their measurements taken after the procedure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Prothrombin Time (PT) | -0.23 second |
p-value: 0.199.8% CI: [-0.68, 0.23]paired t-test
Primary
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)
Time frame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Population: Only 25 patients had their postoperative measurements taken.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Total Bilirubin | 0.01 mg/dl |
Secondary
Diagnostic Accuracy-albumin
Albumin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-albumin | 55 probability |
Secondary
Diagnostic Accuracy-ALK
ALK was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-ALK | 65 probability |
Secondary
Diagnostic Accuracy-ALT
ALT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-ALT | 76 probability |
Secondary
Diagnostic Accuracy-AST
AST was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-AST | 72 probability |
Secondary
Diagnostic Accuracy-ICG k Value
ICG k value was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-ICG k Value | 53 probability |
Secondary
Diagnostic Accuracy-multiple Factor
We also built a multivariable model using all preoperative liver function tests and ICG k clearance values to predict NASH (nonalcoholic steatohepatitis) from pre-RYGB values. AUC was used to assess the prediction performance of those multiple factors. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 95% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
Population: Because all the pre-operative liver functions (AST, ALT, ALK, bilirubin, albumin, PT, and ICG k ) were used and 98 patients had PTT measured.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-multiple Factor | 0.82 probability |
Secondary
Diagnostic Accuracy-PT
PT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-PT | 54 probability |
Secondary
Diagnostic Accuracy-PTT
PTT (Partial Thromboplastin Time) was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-PTT | 46 probability |
Secondary
Diagnostic Accuracy-total Bilirubin
The total bilirubin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
Time frame: before RYGB surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Roux-en-Y Gastric Bypass (RYGB) | Diagnostic Accuracy-total Bilirubin | 53 probability |