Hepatic Effects of Gastric Bypass Surgery
2020년 6월 18일 업데이트: The Cleveland Clinic
Long Term Hepatic Effects of Gastric Bypass Surgery
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
106
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44159
- Cleveland Clinic
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- BMI > 40.
- Documented failed non-surgical treatment for morbid obesity.
- Ability to undergo long-term follow-up after LGBS.
Exclusion Criteria:
- BMI < 40.
- Subject age < 18 years.
- Inability to undergo long-term follow-up after LGBS (living distance > 300 miles).
- Patients with known ESLD.
- Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy.
- Patients with known iodine sensitivity or allergy.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Aspartate Transaminase (AST) Change
기간: 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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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)
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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
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Alanine Transaminase (ALT) Change
기간: 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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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)
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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
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Alkaline Phosphate (ALK)
기간: 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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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
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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
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Total Bilirubin
기간: 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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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)
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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
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Albumin
기간: 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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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)
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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)
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Prothrombin Time (PT)
기간: 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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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)
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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)
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Partial Thromboplastin Time (PTT)
기간: 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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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)
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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)
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Indocyanine Green (ICG) K Value
기간: 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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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.
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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)
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Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis)
기간: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
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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%).
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when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
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Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation
기간: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
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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.
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when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
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Fibrosis
기간: after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
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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
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after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
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Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon
기간: once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
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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
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once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Accuracy-AST
기간: before RYGB surgery
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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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before RYGB surgery
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Diagnostic Accuracy-ALT
기간: before RYGB surgery
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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.
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before RYGB surgery
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Diagnostic Accuracy-ALK
기간: 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.
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before RYGB surgery
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Diagnostic Accuracy-total Bilirubin
기간: before RYGB surgery
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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
기간: 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).
|
before RYGB surgery
|
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Diagnostic Accuracy-PTT
기간: 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).
|
before RYGB surgery
|
|
Diagnostic Accuracy-ICG k Value
기간: 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).
|
before RYGB surgery
|
|
Diagnostic Accuracy-albumin
기간: 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).
|
before RYGB surgery
|
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Diagnostic Accuracy-multiple Factor
기간: 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).
|
before RYGB surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Brian M. Parker, MD, The Cleveland Clinic
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 6월 1일
기본 완료 (실제)
2014년 2월 1일
연구 완료 (실제)
2014년 9월 1일
연구 등록 날짜
최초 제출
2008년 6월 18일
QC 기준을 충족하는 최초 제출
2008년 6월 18일
처음 게시됨 (추정)
2008년 6월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 18일
마지막으로 확인됨
2020년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 07-877
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