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临床试验/NCT04734821
NCT04734821招募中不适用

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

IHU Strasbourg2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月1日最近更新:
适应症

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

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)

研究者

发起方
IHU Strasbourg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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