Trial Outcomes & Findings for Hepatic Effects of Gastric Bypass Surgery (NCT NCT00701376)

NCT ID: NCT00701376

Last Updated: 2020-06-19

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 106 participants
• Primary outcome timeframe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
• Results posted on: 2020-06-19

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	106
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Five patients were missing on this varialbe

Baseline characteristics by cohort

Measure	Roux-en-Y Gastric Bypass (RYGB) n=106 Participants 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.
Age, Continuous	46 years STANDARD_DEVIATION 11 • n=106 Participants
Sex: Female, Male Female	70 Participants n=101 Participants • Five patients were missing on this varialbe
Sex: Female, Male Male	31 Participants n=101 Participants • Five patients were missing on this varialbe
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=106 Participants
Race (NIH/OMB) Asian	0 Participants n=106 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=106 Participants
Race (NIH/OMB) Black or African American	0 Participants n=106 Participants
Race (NIH/OMB) White	90 Participants n=106 Participants
Race (NIH/OMB) More than one race	0 Participants n=106 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=106 Participants
Body Mass Index (BMI)	48 kg/m^2 STANDARD_DEVIATION 8 • n=106 Participants
Obesity Level Morbid Obesity	93 Participants n=106 Participants
Obesity Level Severe Obesity	11 Participants n=106 Participants
Obesity Level Other	2 Participants n=106 Participants
Duration of Obesity	26 years STANDARD_DEVIATION 12 • n=104 Participants • Two patients were missing on this variable

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Aspartate Transaminase (AST) Change

-6.32 U/L Interval -15.6 to 2.94

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Alanine Transaminase (ALT) Change

-7.56 U/L Interval -22.0 to 6.83

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Alkaline Phosphate (ALK)

5.84 U/L Interval -7.55 to 19.2

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Total Bilirubin

0.01 mg/dl Interval -0.15 to 0.17

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Albumin

-0.2 g/dL Interval -0.38 to -0.02

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=25 Participants 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.

Prothrombin Time (PT)

-0.23 second Interval -0.68 to 0.23

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=6 Participants 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.

Partial Thromboplastin Time (PTT)

-1.72 second Interval -8.68 to 5.25

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=19 Participants 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.

Indocyanine Green (ICG) K Value

0.01 K(ICG) Value Interval -0.04 to 0.06

PRIMARY outcome

Timeframe: 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.

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%).

Outcome measures

Measure	Roux-en-Y Gastric Bypass (RYGB) n=15 Participants 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.
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) <5%	11 Participants
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) 5-33%	3 Participants
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) 34-66%	1 Participants
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis) >66%	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Roux-en-Y Gastric Bypass (RYGB) n=15 Participants 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.
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation No foci	10 Participants
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation < 2 foci / 200×	4 Participants
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation 2-4 foci / 200×	1 Participants
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation > 4 foci / 200×	0 Participants

PRIMARY outcome

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

Population: Only 15 patients had repeat liver biopsies

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

Outcome measures

Measure	Roux-en-Y Gastric Bypass (RYGB) n=15 Participants 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.
Fibrosis None	6 Participants
Fibrosis Perisinusoidal or periportal	0 Participants
Fibrosis 1A - Mild, zone 3, perisinusoidal	0 Participants
Fibrosis 1B - Moderate, zone 3, perisinusoidal	1 Participants
Fibrosis 1C - Portal/periportal	5 Participants
Fibrosis 2 - Perisinusoidal and portal/periportal	2 Participants
Fibrosis 3 - Bridging fibrosis	1 Participants
Fibrosis 4 - Cirrhosis	0 Participants

PRIMARY outcome

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

Population: Only 15 patients had repeat liver biopsies

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

Outcome measures

Measure	Roux-en-Y Gastric Bypass (RYGB) n=15 Participants 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.
Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon Few Balloon Cells	3 Participants
Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon Absent	12 Participants
Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon Many cells / prominent ballooning	0 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=101 Participants 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.

Diagnostic Accuracy-AST

72 probability Interval 61.0 to 82.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=101 Participants 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.

Diagnostic Accuracy-ALT

76 probability Interval 66.0 to 85.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=101 Participants 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.

Diagnostic Accuracy-ALK

65 probability Interval 53.0 to 77.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=101 Participants 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.

Diagnostic Accuracy-total Bilirubin

53 probability Interval 41.0 to 64.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=98 Participants 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.

Diagnostic Accuracy-PT

54 probability Interval 41.0 to 67.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=36 Participants 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.

Diagnostic Accuracy-PTT

46 probability Interval 26.0 to 66.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=100 Participants 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.

Diagnostic Accuracy-ICG k Value

53 probability Interval 41.0 to 66.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=101 Participants 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.

Diagnostic Accuracy-albumin

55 probability Interval 43.0 to 66.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure

Roux-en-Y Gastric Bypass (RYGB) n=98 Participants 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.

Diagnostic Accuracy-multiple Factor

0.82 probability Interval 0.73 to 0.9

Adverse Events

Liver Function

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Liver Function n=106 participants at risk 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
Cardiac disorders Death	1.9% 2/106 • Number of events 2
Gastrointestinal disorders Bowel obstruction	0.94% 1/106 • Number of events 1
Blood and lymphatic system disorders pulmonary embolism,	1.9% 2/106 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Brian Parker, MD

Cleveland Clinic

Phone: 216-444-9950

Email: parkerb1@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place