Prospective Study on the Contribution of Fluorescence in the Guidance of Lymphadenectomy and in Peroperative Evaluation of Pre-anastomotic Tissue Perfusion in Laparoscopic Esogastric Oncologic Resections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluation of the usefulness of ICG fluorescence to guide lymphadenectomy in oncological esogastric resections
研究概览
简要总结
A high number of resected lymph nodes is an independent prognostic factor for improved survival after esophagectomy or gastrectomy for cancer. The quality of the lymphadenectomy is operator-dependent, as is the evaluation of the vascularization of the digestive structures that are anastomosed to restore digestive continuity after esophago-gastric resection. The aim of the study is to evaluate the impact of Indocyanine Green (ICG) and near infra-red (NIR) fluorescence imaging guidance in terms of number of lymph nodes resected and quality of gastrointestinal tract anastomoses in esophagogastric cancer surgery.
详细描述
In cancer surgery, an oncological resection involves the resection of the primary lesion but also of the loco-regional lymph nodes.In the large retrospective study of the Global Group of esophageal cancer collaboration (WECC) involving 3,572 patients having had resection of the main tumor (60% adenocarcinomas, 40% squamous cell carcinomas), a high total number of resected lymph nodes has been shown to be an independent prognostic factor of improved survival after esophagectomy for esophageal or gastroesophageal junction cancer. The maximum survival at 5 years is modulated by the T classification: it is recommended to resect 10 lymph nodes for a "pT1" stage tumor (pathologic tumor stage 1), 20 for a "pT2" stage and at least 30 for a "pT3" / "T4" stage. This number is important in terms of staging, the decision of adjuvant treatments and prognostic. A recent European study showed that the average number of resected lymph nodes was 20. In addition, lymphatic drainage is variable according to the type and location of tumors, involving an adapted lymphadenectomy strategy to each situation.
Also in gastric cancer, a complete resection (R0) and adequate lymphadenectomy are predictive factors for healing and long-term survival. Lymphadenectomy is adapted to the type, stage and location of the primary lesion.
In the U.S., the National Cancer Network guidelines recommend a D2 lymphadenectomy or a minimum of 15 lymph nodes (Lymph Node, LN) recovered.However, most international guidelines consider the recovery of only 15 LNs is insufficient. A recent Korean study on more than 25,000 patients showed that the maximum survival advantage is observed by performing a lymphadenectomy with a minimum of 29 LNs recovered. The experience of Western surgeons is much less than that of surgeons in Asia, and it seems obvious that an intraoperative guidance method would be a major support for the decision making in real time and thus remove the current variability related to the level of experience of the surgeon.
In addition, oncology surgery includes in the vast majority of cases a resection of an segment of the digestive tract and requires the restoration of digestive continuity by simple anastomosis and/or by interposition of another intestinal segment.
This stage of the surgical procedure is critical, since any anastomotic leakage is burdened with a risk of complication sometimes lethal. The surgeon's experience, which allows him to evaluate visually the vascularization of the tissue to be anastomosed, is therefore fundamental to prevent the problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman over 18 years old.
- •Patient with resectable primitive esophageal or gastric cancer confirmed by biopsy without distant metastases
- •Patient with no contraindications to anaesthesia and performance of esophageal and/or gastric surgery
- •Patient able to receive and understand information related to the study and give written informed consent.
- •Patient affiliated to the French social security system.
排除标准
- •Patient undergoing emergency surgery (hemorrhage, occlusion or perforation).
- •Presence of distant metastasis
- •Patient at risk of allergy to indocyanine green or to other fluorescent compounds
- •Pregnant or lactating patient.
- •Patient in exclusion period (determined by a previous or a current study).
- •Patient under the protection of justice.
- •Patient under guardianship or trusteeship.
- •Patient deprived of liberty
结局指标
主要结局
Evaluation of the usefulness of ICG fluorescence to guide lymphadenectomy in oncological esogastric resections
时间窗: During the surgical procedure
Additional detection (YES-NO) of lymph nodes after activation of the NIR fluorescence guidance system during lymphadenectomy.
次要结局
- Evaluation of the impact of fluorescence guidance on the number of resected lymph nodes in oncological esogastric resections(7 days after operation when pathologic result was reported)
- Evaluation of the impact of fluorescence guidance in intraoperative evaluation of pre-anastomotic tissue perfusion(30 days after operation)
