Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
研究概览
简要总结
Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
详细描述
Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.
This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years old
- •Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
- •Patient with a complete clinical examination performed
- •Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
- •Patient able to receive and understand information relating to the study and give informed written consent
- •Patient affiliated to the French social security system
排除标准
- •Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT <60%, TCA> 40 s and platelets <60,000 / mm3)
- •Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
- •Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
- •Pregnant or breastfeeding patient
- •Patient in exclusion period (determined by a previous study or in progress)
- •Patient under legal protection
- •Patient under guardianship or trusteeship
研究组 & 干预措施
Peripancreatic and distant lymph node assessment
All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer
干预措施: Echoendoscopy (Diagnostic Test)
结局指标
主要结局
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
时间窗: 1 month
Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
时间窗: 1 month
Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
次要结局
- Location of hidden lymph node metastases(1 day)
- Number of distant nodes detected during the endoscopic ultrasound(1 day)
- Rate of metastases actually diagnosed(1 month)
- Measurement of the additional costs generated by materials required for preoperative elastography(1 day)
- Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound(1 day)
- Number of distant malignant lymph nodes(1 month)
- Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site(1 day)
- Measurement of the operating time required to perform preoperative elastography(1 day)
- Impact of sterile black ink marking of distant nodes during the preoperative EA(1 day)
- Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence(1 day)
- Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence(1 day)