Hepatic Effects of Gastric Bypass Surgery
2020年6月18日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
106
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Ohio
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Cleveland、Ohio、アメリカ、44159
- Cleveland Clinic
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Aspartate Transaminase (AST) Change
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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.
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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)
時間枠：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
時間枠：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.
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when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
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Fibrosis
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic Accuracy-AST
時間枠：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).
|
before RYGB surgery
|
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Diagnostic Accuracy-ALT
時間枠：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.
|
before RYGB surgery
|
|
Diagnostic Accuracy-ALK
時間枠：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.
|
before RYGB surgery
|
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Diagnostic Accuracy-total Bilirubin
時間枠：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.
|
before RYGB surgery
|
|
Diagnostic Accuracy-PT
時間枠：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
|
|
Diagnostic Accuracy-PTT
時間枠：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
時間枠：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
時間枠：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
|
|
Diagnostic Accuracy-multiple Factor
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Brian M. Parker, MD、The Cleveland Clinic
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年6月1日
一次修了 (実際)
2014年2月1日
研究の完了 (実際)
2014年9月1日
試験登録日
最初に提出
2008年6月18日
QC基準を満たした最初の提出物
2008年6月18日
最初の投稿 (見積もり)
2008年6月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年6月19日
QC基準を満たした最後の更新が送信されました
2020年6月18日
最終確認日
2020年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 07-877
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