Use of Diffusion-weighted MRI for the Detection of Liver Metastases in Potentially Resectable Pancreatic Adenocarcinomas: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 主要终点
- The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
研究概览
简要总结
The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 year old,
- •no general contraindication for pancreatic surgery,
- •pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
- •CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
- •Resectability confirmed by a medical/surgical multidisciplinary review,
- •if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
- •informed consent prepared and signed.
排除标准
- •locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
- •unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
- •metastasis of any organ visible on thoraco-abdominopelvic CT scan
- •time lag exceeding 21 days between diffusion-weighted MRI and surgery
- •contraindication for an MRI
研究组 & 干预措施
diffusion-weighted nuclear magnetic resonance imaging
detection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma
干预措施: Diffusion-weighted nuclear magnetic resonance imaging (Radiation)
结局指标
主要结局
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
时间窗: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
The primary outcome will be measured at the time of diagnosis of liver metastasis, either based on histological study (within one month after surgery or biopsy) or based on follow-up (maximum time frame of 24 months after inclusion).
次要结局
- Diagnostic performance of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma(At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).)
- Rate of patients for whom the therapeutic strategy is modified as a consequence of the diagnosis of liver metastasis on diffusion-weighted MRI(At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).)