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临床试验/NCT05369117
NCT05369117尚未招募不适用

To Evaluate Whether the Clinical Efficacy of Laparoscopic Lymph Node Dissection With Indocyanine Green Tracer is Better Than Without Indocyanine Green Tracer

Guangyong Zhang0 个研究点目标入组 1,016 人开始时间: 2022年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,016
主要终点
Three-year disease-free survival rate

研究概览

简要总结

Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.

详细描述

Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.By recruiting patients and signing informed consent, randomized control was used to divide patients into the experimental group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery) and the control group (fluorescently labeled fluorescently laparoscopic proximal gastric cancer surgery). In the experimental group, indocyanine green fluorescence labeling was performed under gastroscope before surgery and internal jugular vein puncture was performed routinely for better fluid replenishment after surgery. Lymph nodes and diseased stomach tissues were collected during operation. Postoperative assessment was made for ICU support, routine acid-suppressing therapy, prophylactic antibiotics, analgesia, and nausea suppression. The patients were followed up for 3 years. The primary outcome was 3-year disease-free survival, and the secondary outcome was lymph node positive rate, early complication rate and surgical mortality. The investigators plan to obtain more precise evidence-based medical evidence through this project.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old < age < 75 years old
  • The primary gastric lesion was pathologically diagnosed as proximal gastric adenocarcinoma by endoscopic biopsy (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR)
  • Preoperative clinical staging was CT1-4A, N-/+, and M0, according to AJCC-8th TNM tumor staging
  • No distant metastasis was found in preoperative examination, and the tumor did not directly invade pancreas, spleen or other adjacent organs
  • ECOG physical status score 0/1 before surgery Preoperative ASA score I-III
  • (7) Informed consent of patients

排除标准

  • Suffering from severe mental illness
  • Severe complications cannot tolerate surgery
  • Simultaneous surgical treatment of other diseases is required
  • History of gastric surgery (including ESD/EMR for gastric cancer)
  • Tumors involving esophagus or duodenum were confirmed preoperatively
  • Neoadjuvant therapy has been implemented
  • Leather stomach
  • Refusing laparoscopic surgery

结局指标

主要结局

Three-year disease-free survival rate

时间窗: Through study completion,an average of 3 years

To evaluate the difference of 3-year disease-free survival rate between the experimental group and the control group

次要结局

  • lymph node positive rate(up to 1 week)
  • operative mortality(up to 24 hours)
  • Incidence of early complications(up to 1 week)

研究者

发起方
Guangyong Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guangyong Zhang

Director of General Surgery department

Qianfoshan Hospital

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