Long Term Hepatic Effects of Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Aspartate Transaminase (AST) Change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented failed non-surgical treatment for morbid obesity.
- •Ability to undergo long-term follow-up after LGBS.
排除标准
- •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.
结局指标
主要结局
Aspartate Transaminase (AST) Change
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Alkaline Phosphate (ALK)
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Total Bilirubin
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Prothrombin Time (PT)
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis)
时间窗: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
To compare the distribution of NAS steatosis stage from before surgery to when patients lost 60% of their preoperative excess weight or weight loss had plateaued. The NAFLD activity score (NAS) from the NASH clinical Clinic Research Network is the unweighted sum of scores for steatosis, lobular inflammation, and ballooning hepatocyte degeneration, and ranges from zero to eight points. The histological reporting for grading steatosis was based on a scale of 0 to 3, with 0 being no steatosis (\<5%), 1 being mild steatosis (involving 5-33% of the biopsy specimen), 2 being moderate steatosis (involving 34-66% of the specimen), and 3 being severe (involving \>66%).
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation
时间窗: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Lobular inflammation was similarly scored by number of foci per 200× magnification field (0 no foci: 1 \< 2 foci: 2, 2-4 foci; 3, \>4 foci) on biopsy specimen under microscope. This outcome was compared on its distribution before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Fibrosis
时间窗: after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
Fibrosis was measured from before surgery to after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued through biopsies
Alanine Transaminase (ALT) Change
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Indocyanine Green (ICG) K Value
时间窗: 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.
Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon
时间窗: once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
Ballooning hepatocyte degeneration was scored as 0 (absent), 1 (few, difficult to identify), 2 (many, easily identified). This was to assess the change in the distribution of NAS hepatocyte ballon between before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued
Albumin
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure versus before the procedure)
Partial Thromboplastin Time (PTT)
时间窗: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To measure the change of PTT from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
次要结局
- Diagnostic Accuracy-ALT(before RYGB surgery)
- Diagnostic Accuracy-AST(before RYGB surgery)
- Diagnostic Accuracy-ICG k Value(before RYGB surgery)
- Diagnostic Accuracy-albumin(before RYGB surgery)
- Diagnostic Accuracy-ALK(before RYGB surgery)
- Diagnostic Accuracy-PT(before RYGB surgery)
- Diagnostic Accuracy-PTT(before RYGB surgery)
- Diagnostic Accuracy-multiple Factor(before RYGB surgery)
- Diagnostic Accuracy-total Bilirubin(before RYGB surgery)