Aplicación Del ICG En La Linfadenectomía D2 Laparoscópica Del Cáncer Gástrico Localmente Avanzado: Ensayo Clínico Aleatorizado Multicéntrico.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- total nodes resected
研究概览
简要总结
Gastric cancer is a frequent neoplasm in the world, presenting more than one million new cases and around 768,000 deaths in the data registered in 2020. Among the therapeutic options for gastric cancer, surgery is an essential pillar for its treatment. Gastric cancer surgery consists of gastric resection with negative margins and radical lymphadenectomy in patients without distant metastases. It has been demonstrated over the years that radical lymphadenectomy in gastric cancer allows for adequate staging and improved long-term survival.
In order to perform a correct staging using the TNM system, it is necessary to resect at least 15 lymph nodes in the radical lymphadenectomy. For radical lymphadenectomy staging, the Japanese Gastric Cancer Association defined and subdivided nodal stations. Three types of lymphadenectomy are described according to oncologic gastric resections (D1, D1+ and D2), with D2 lymphadenectomy being the standard of treatment for locally advanced gastric tumors. Performing an insufficient or inadequate lymphadenectomy has been shown to negatively impact survival after gastrectomy in such a cohort.
The development of technology based on fluorescence guided by indocyanine green could improve the technique and results of D2 lymphadenectomy in patients with gastric cancer. There is evidence that the application of ICG in D2 lymphadenectomy increases the number of resected nodes, however, studies of higher scientific quality (randomized clinical trials) are needed. Furthermore, most studies in this field have focused on Eastern countries (Japan, Korea and China), where the percentage of early tumors and chemotherapy treatment is different from Western centers.
Therefore, we propose a multicenter randomized clinical trial aimed at evaluating whether the application of ICG-guided fluorescence-based technology in D2 lymphadenectomy of locally advanced gastric cancer increases the number of resected nodes, improves the oncologic quality of the lymphadenectomy, and thus may increase overall survival and disease-free survival at 2 and 5 years postoperatively.
详细描述
Objective:
- Mean total number of nodes/ nodal ratio (number of positive nodes divided by the number of total nodes).
Secondary objective:
- Overall Survival and disease- free survival at 2 and 5 years.
- Number of metastatic nodes
- Complications measured with the Comprehensive Complication Index (CCI)
- Intraoperative bleeding volume
- Surgical time (minutes)
- Days of hospitalization (days) Randomized clinical trial 1:1. The patient will be included once the perioperative chemotherapy treatment is completed. The investigator at each center will explain the study, and if the patient consents to participate, he/she will sign the informed consent form (IC). After which, the investigator of each center will contact the principal investigator of the University Hospital of Navarra (HUN), who will perform the randomization and communicate the result by email to the participating center.
Requirements for participating centers:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •T2-T4a, N+, M0 on preoperative study
- •ASA I-III
- •Laparoscopic surgery
排除标准
- •- Previous gastric abdominal surgery
- •Cognitive impairment
- •Allergic to iodine
- •Synchronous neoplasm
- •Stroke in the last 6 months
- •Angina or AMI in the last 6 months
- •Plastic lymphitis
- •Open surgery
研究组 & 干预措施
Control Group, Subtotal/Total gastrectomy with D2 lymphadenectomy LPS ( standar of care)
- Tumor localization and assessment of resectability
- Omentectomy
- Ligation and dissection of the right gastroepiploic vessels at their origin.
- Dissection of lymph node group 6
- Opening of the pars flaccida of the lesser omentum.
- Dissection and ligation of the pyloric artery at its origin
- Dissection of ganglionic group 5
- Dissection and section of the first portion of the duodenum.
- Lymphadenectomy D2: 7, 8, 9, 9, 11 p, 12a
- Ligation and section of the coronary artery at origin
- Group 1 lymphadenectomy
- Gastric section with negative margin
- Removal of the specimen
- Reconstruction according to the usual technique
Ex vivo analysis of the specimen in the surgical block. A dissection of the D2 lymphadenectomy lymph node groups will be performed including the following groups according to the Japanese Gastric Cancer Association Classification:
- Group 7, 8, 9, 11 p, 12 a. Each lymph node group will be sent in a separate labeled sample bottle to the pathology department.
Intervention group: ICG administration
ICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.
To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water
Standard Total or Subtotal gastrectomy and D2 lymphadenectomy will be performed. After removal of the specimen, we will use ICG mode and evaluate if there are foci of uptake in the territory of the D2 lymphadenectomy.
- If there are foci of uptake, dissect and resect them. Identified in a separate anatomic pathology jar and labeled with the name of the corresponding anatomic region with ICG
干预措施: ICG administration (Procedure)
结局指标
主要结局
total nodes resected
时间窗: 18 months
Mean of the total nodes resected in the D2 lymphadenectomy
Nodal ratio
时间窗: 18 months
number of positive nodes divided by number of total nodes
次要结局
- Overall Survival(2 and 5 years)
- Disease-free survival(2 and 5 years)
- Number of metastatic nodes(18 months)
- Comprehensive Complication Index(30 days after surgery)
- Intraoperative bleeding volume(18 months)
- Surgical time(18 months)
- Days of hospitalization(18 months)
- Correlation of positive lymph nodes in anatomical pathology and with ICG uptake(18 months)
研究者
Ines Eguaras
Principal investigator
Hospital of Navarra