NCT04101162Unknown不适用
Diagnostic Accuracy in a New Ultrasound Software Compared to Histology for Non Alcoholic Fatty Liver Disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH) in Morbidly Obese Individuals Undergoing Bariatic Surgery and/or Cholecystectomy
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- diagnostic accurancy of ATI in obese patients
研究概览
简要总结
Evaluate the diagnostic accuracy of the new ultrasound software vs hepatic histology, the current reference standard for the diagnosis of NAFLD and NASH in 20 obese patients (BMI> 30) candidates for laparoscopic bariatric surgery and / or cholecystectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are candidates for bariatric surgery between the ages of 18 and 65,
- •BMI> 40 kg / m2, in the absence of any other comorbidity
- •BMI> 35 kg / m2, in the presence of comorbidities among those classically considered to be associated with obesity
- •ICM> 30 kg / m2, in the presence of T2DM not in glycometabolic compensation
- •Patients who are candidates for laparoscopic cholecystectomy for symptomatic calculi with BMI> 30
排除标准
- •Age ≤ 18 or ≥ 65
- •Any concurrent surgical procedure except cholecystectomy and hiatal hernia repair
- •Conversion into laparotomy surgery
- •Post-operative complications requiring new surgical treatment
- •Patient not compliant in the follow-up
结局指标
主要结局
diagnostic accurancy of ATI in obese patients
时间窗: 6 months
a new ultrasound software compared with liver biopsy in obese patients.
次要结局
未报告次要终点
研究者
Gianfranco Silecchia
Professor
University of Roma La Sapienza
研究点 (2)
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