Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
研究概览
简要总结
Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm.
Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.
The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.
This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with progressive colorectal cancer in intra-abdominal surgery requiring resection + / - Chemotherapy Hyperthermic Intraperitoneal
- •Aged 18 to 70 inclusive
- •Signature information form and consent by the patient
排除标准
- •Pregnant women, a urine pregnancy test or blood will be realized within 72 hours before surgery
- •Contraindication to surgery
- •Diagnosis not confirmed colorectal adenocarcinoma
- •Persons major subject of legal protection or unable to consent
研究组 & 干预措施
patients
Patients (Aged 18 to 70 inclusive) with progressive colorectal cancer in intra-abdominal surgery requiring resection +/- Chemotherapy Hyperthermic Intraperitoneal
干预措施: indocyanine green (Drug)
结局指标
主要结局
Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
时间窗: At the end of the surgery
Sensitivity (true positive) of the fluorescence ex vivo compared to histological analysis s detected by fluorescence ex vivo
次要结局
- Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo peritoneal cancer index (PCI) score with and without fluorescence(At the end of the surgery)
- Specificity (true negative) of the in-vivo fluorescence compared to histological analysis s detected by fluorescence ex vivo PCI score with and without fluorescence(At de begining of the surgery)