Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
研究概览
简要总结
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.
详细描述
A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), liver function tests, lipogram, homeostatic model assessment of insulin resistance (HOMA-IR), and steatosis were also assessed using controlled attenuation parameter (CAP), and intra operative liver biopsies were obtained. , The presence of steatosis and steatohepatitis were histologically assessed by two expert pathologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
- •Able to give written informed consent.
- •Scheduled, independently from this study, to have a liver biopsy (LB).
- •Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
- •BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
- •Unsuccessful nonoperative weight loss attempts.
- •Mental health clearance.
- •Recent updates have included patients with a BMI of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy.
排除标准
- •Patients with ascites.
- •Pregnant women.
- •Patients with any active implantable medical device (such as pacemaker or defibrillator).
- •Patients who had undergone liver transplantation.
- •Patients with cardiac failure and significant valvular disease.
- •Patients with hemochromatosis.
- •Patients who refused to undergo liver biopsy or blood tests.
- •Patients with alcohol consumption above recommended limits (>14 units/week for women and >21 units/week for men; 1 unit = 8 g of ethanol).
- •Patients with a confirmed diagnosis of active malignancy or another terminal disease.
- •Patients participating in another clinical trial within the preceding 30 days
结局指标
主要结局
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
时间窗: 55 months
Compare the histological assessment of steatosis and steatohepatitis with non invasive procedures.
次要结局
未报告次要终点