New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Quantitative MRI parameters
研究概览
简要总结
The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI.
Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.
To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Adults (aged 18 to 65 years) with a planned for bariatric surgery (sleeve gastrectomy) according to HAS criteria
- •Patients with severe obesity (BMI≥35)
排除标准
- •Patients with problem of alcohol abuse (previous or current)
- •Patients with problems of understanding
- •Patients with previous acute or chronic pancreatitis
- •Patients with contraindication to MRI (active implantable medical devices, pacemaker, claustrophobia …)
- •Inability to undergo MRI due to weight excess
- •Pregnant or breastfeeding woman
- •Absence of free and informed consent
- •Non affiliation to a social security regime or CMU (Universal health coverage)
- •Patient under AME (State medical aid)
- •Patient deprived of freedom, subject under a legal protective measure
- •Patients who have already had bariatric surgery
- •Secondary exclusion criteria :
- •Patients who have undergone bariatric surgery other than a sleeve gastrectomy
研究组 & 干预措施
MRI before and 6 months after bariatric surgery
Recruitment of patient with planned bariatric surgery in Louis Mourier Hospital by the nutritionist, during the preoperative day hospitalisation (performed during the multidisciplinary preparation for bariatric surgery) when patients are deemed eligible for bariatric surgery according to HAS (High Authority of Health) criteria.
Programming of MRI in the month between preoperative visit and surgery. During this exam without injection of contrast agents in the radiology department of Louis Mourier Hospital, additional sequences with specific acquisitions as previously validated in humans will be performed for the study.
Bariatric surgery will be performed as in usual care in Louis Mourier hospital. The same MRI will be performed in day hospitalization scheduled 6 months after surgery.
干预措施: Magnetic Resonance Imaging (Radiation)
结局指标
主要结局
Quantitative MRI parameters
时间窗: 6 months after inclusion
Pancreatic fat content
次要结局
- Metabolic and anthropometric parameters before and after bariatric surgery(6 months after inclusion)
- lipids parameters(6 months after inclusion)