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临床试验/NCT02682173
NCT02682173已完成不适用

MRI Fat Quantification of the Liver, Subcutaneous and Visceral Fatty Tissue in Patients Before and After Bariatric Surgery

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Liver fat quantification

研究概览

简要总结

Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

详细描述

Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. Complications are rare; however, the method is invasive and carries the risk of bleeding. Therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. Unidimensional transient elastography (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be applied.

In recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore MRI has become an important tool for fat quantification.

Up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of MRI fat quantification. However, in these studies single voxel spectroscopy was used. In contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)

排除标准

  • substance abuse
  • history of gastrointestinal disorders
  • pace-maker
  • claustrophobia

研究组 & 干预措施

Laparoscopic gastric bypass

Active Comparator

MR Abdomen in morbidly obese patients receiving gastric bypass

干预措施: MR Abdomen (Other)

Laparoscopic sleeve gastrectomy

Active Comparator

MR Abdomen morbidly obese patients receiving sleeve gastrectomy

干预措施: MR Abdomen (Other)

结局指标

主要结局

Liver fat quantification

时间窗: within 3, 6 and 12 months of surgery

change in fat quantification; measurement of fat rate in the organ

次要结局

  • Visceral fat quantification(within 3, 6 and 12 months of surgery)
  • Subcutaneous fat quantification(within 3, 6 and 12 months of surgery)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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