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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M. Parker, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44159 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 84 patients did not have AST measured after the surgery | Posted | Mean | 99.8% Confidence Interval | U/L | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | death, heart attach fluid in the lungs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Parker, MD | Cleveland Clinic | 216-444-9950 | parkerb1@ccf.org |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D008110 | Liver Extracts |
| D009339 | Needles |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
| D004864 | Equipment and Supplies |
| D003581 | Cytodiagnosis |
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|
| 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 |
| before RYGB surgery |
| 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. | before RYGB surgery |
| 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. | before RYGB surgery |
| 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. | before RYGB surgery |
| 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). | before RYGB surgery |
| 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). | before RYGB surgery |
| 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). | before RYGB surgery |
| 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). | before RYGB surgery |
| 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). | before RYGB surgery |
| years |
|
| Sex: Female, Male | Five patients were missing on this varialbe | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Obesity Level | Morbid obesity is BMI between 35 - 40 Kg/m^2; Severe obesity is BMI greater than 40 kg/m^2. | Count of Participants | Participants |
|
| Duration of Obesity | Two patients were missing on this variable | Mean | Standard Deviation | years |
|
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| 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) | 84 patients did not have ALT measured | Posted | Median | 99.8% Confidence Interval | U/L | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure |
|
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| 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 | Posted | Mean | 99.8% Confidence Interval | U/L | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure |
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| 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) | Only 25 patients had their postoperative measurements taken. | Posted | Median | Inter-Quartile Range | mg/dl | from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure |
|
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|
| 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) | Only 25 patients had their postoperative measurements taken. | Posted | Mean | 99.8% Confidence Interval | g/dL | 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) |
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| 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) | Only 25 patients had their measurements taken after the procedure. | Posted | Mean | 99.8% Confidence Interval | second | 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) |
|
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| 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) | Only 6 patients had their PTT measured after the surgery | Posted | Mean | 99.8% Confidence Interval | second | 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) |
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| 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. | Only 19 patients had their post-surgery ICG K measurement | Posted | Mean | 99.8% Confidence Interval | K(ICG) 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) |
|
|
|
| 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%). | The outcome shows the distribution result of NAS steatosis of patients after the surgery. Only 15 people had agreed to have repeat liver biopsies. | Posted | Count of Participants | Participants | when patients lost 60% of their preoperative excess weight or weight loss had plateaued. |
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| 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. | Only 15 people had agreed to have repeat liver biopsies. | Posted | Count of Participants | Participants | when patients lost 60% of their preoperative excess weight or weight loss had plateaued. |
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| 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 | Only 15 patients had repeat liver biopsies | Posted | Count of Participants | Participants | after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued |
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| 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 | Only 15 patients had repeat liver biopsies | Posted | Count of Participants | Participants | once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery |
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| 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). | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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| 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. | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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| 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. | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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| 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. | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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| 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). | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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| 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). | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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|
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| 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). | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
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|
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| 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). | Posted | Number | 99.4% Confidence Interval | probability | before RYGB surgery |
|
|
|
| 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). | Because all the pre-operative liver functions (AST, ALT, ALK, bilirubin, albumin, PT, and ICG k ) were used and 98 patients had PTT measured. | Posted | Number | 95% Confidence Interval | probability | before RYGB surgery |
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|
|
| 2 |
| 106 |
| 2 |
| 106 |
| 0 |
| 106 |
|
| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | Patient re hospitalized, symptoms improved |
|
| pulmonary embolism, | Blood and lymphatic system disorders | Non-systematic Assessment | rehospitalization, |
|
Not provided
Not provided
| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| >66% |
|
| > 4 foci / 200× |
|
| 1B - Moderate, zone 3, perisinusoidal |
|
| 1C - Portal/periportal |
|
| 2 - Perisinusoidal and portal/periportal |
|
| 3 - Bridging fibrosis |
|
| 4 - Cirrhosis |
|