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Clinical Study on Using Laparoscopic Sentinel Lymph Node Navigation Combined With Dual Endoscopy Surgery for Early Gastric Cancer

2026年7月13日 更新者:wangdongsheng

Safety and Effectiveness of Laparoscopic Sentinel Lymph Node Navigation Combined With Dual-endoscope Surgery for Early Stomach Cancer: a Prospective, Single-centre, Single-arm Clinical Study

Gastric cancer is a common malignant tumour worldwide, and in China, the incidence and mortality rates of gastric cancer remain high. Standardised surgical treatment is effective, but the normal structure of the stomach undergoes irreversible changes, leading to a series of adverse reactions. At the same time, some early-stage gastric cancer patients cannot have the lesions completely removed endoscopically, and conventional surgery can affect postoperative normal life. Therefore, laparoscopic and endoscopic cooperative surgery has become a focus for precise stomach-preserving surgery. Participants meeting the surgical criteria are selected, and after discussing the treatment plan with their families and signing informed consent forms, relevant examinations are completed. During surgery, lesions are explored together using laparoscopy and endoscopy, then a fluorescent tracer is injected around the lesion and the lesion boundary is marked. Fifteen minutes after injecting the fluorescent tracer, the illuminated perigastric lymph nodes are the sentinel lymph node region (SLNB), and all fluorescent lymph nodes (sentinel lymph nodes) are removed and sent for intraoperative frozen pathology. If the SLNB is negative: a dual-endoscope combined local gastric resection (endoscope combined with laparoscopic local gastric resection or a modified procedure) is performed to completely remove the lesion, ensuring a negative margin. If the SLNB is positive: immediate conversion to laparoscopic-assisted radical gastrectomy (D2 lymph node dissection) is carried out. For SLNB-negative cases, the dual-endoscope combined local gastric resection specimen is placed in a retrieval bag for full removal and examination, with the stomach wall incision then closed by suturing or using a stapler. Postoperative follow-up includes monitoring tumour outcomes and quality of life.

研究概览

详细说明

Stomach cancer is one of the common malignant tumours worldwide, and in China, the incidence and mortality rates of stomach cancer remain high, posing a major public health burden. With the widespread implementation of stomach cancer screening in China, the detection rate of early-stage stomach cancer has significantly increased, now accounting for 19.5% of all stomach cancer cases. Early-stage stomach cancer (T1 stage) has a much better prognosis than advanced-stage cancer, with a 5-year survival rate exceeding 90% after standard treatment. Endoscopic submucosal dissection (ESD), due to its minimally invasive nature and ability to preserve stomach function, has become the standard treatment for certain cT1a-stage stomach cancers. However, for early-stage stomach cancer patients with a higher risk of lymph node metastasis, the lymph node metastasis rate can be close to 20%. In this context, if these patients only undergo endoscopic removal, they may face a higher risk of tumour residue. The traditional standard treatment is radical gastrectomy, usually combined with regional lymph node dissection (D1 or D2). Although this surgery is effective for cancer control, it can cause significant trauma, leading to irreversible changes to the patient's post-operative physiology and function, as well as long-term complications such as malnutrition, reflux oesophagitis and reduced quality of life, which have become key issues affecting the recovery of early-stage stomach cancer patients.

With the development of endoscopic technology (gastroscopy) and laparoscopic minimally invasive surgery, the concept of "function-preserving" surgery for early gastric cancer has been gaining increasing attention. This concept aims to minimise surgical trauma and preserve the anatomical structure and physiological function of the stomach while ensuring oncological safety. Achieving this goal relies heavily on the development and integration of two key techniques. First is Laparoscopic Sentinel Node Navigation Surgery (LSNNS). Sentinel lymph nodes are the first or group of lymph nodes along the primary tumour's lymphatic drainage pathway, and their pathological state is considered to highly predict metastasis in all lymph nodes in that region. In gastric cancer surgery, by injecting tracers (such as the fluorescent dye indocyanine green) under the mucosa around the tumour, and using the magnified view and fluorescence imaging system of laparoscopy, these sentinel lymph nodes can be located and removed in real time for intraoperative rapid pathological examination. The National Cancer Center in South Korea conducted a multicentre phase III randomised controlled clinical trial (SENORITA) on laparoscopic sentinel node navigation surgery for function-preserving surgery in early gastric cancer. In the LSNNS group, 210 patients (81%) underwent stomach-preserving surgery, and the results showed no significant difference in postoperative complication rates, 5-year local recurrence, disease-free survival (DFS), and overall survival (OS) compared to conventional laparoscopic radical gastrectomy. However, the LSNNS group had significantly better postoperative quality of life. These study results suggest that due to the complexity of gastric cancer lymphatic drainage and the skip and uncertain nature of metastasis, detecting the sentinel lymphatic basin (SLB) can provide a more comprehensive understanding of sentinel nodes, offering precise guidance for individualised lymph node dissection and avoiding unnecessary extended lymph node removal, reducing surgical trauma and related complications without compromising oncological outcomes.

Laparoscopic and endoscopic cooperative surgery (LECS) combines the advantages of laparoscopic internal view and operation with the precise localisation and removal capabilities of endoscopy. It's become a hot research topic in stomach-function-preserving surgery in recent years. Endoscopy provides a high-definition view of the mucosal surface from inside the cavity, allowing precise marking of tumour boundaries and submucosal dissection, while laparoscopy offers an external view of the serosal surface, enabling reliable full-thickness gastric wall resection, accurate suturing and regional lymph node inspection and management. Main LECS procedures include laparoscopic-assisted endoscopic full-thickness resection (LAEFR), endoscope-assisted wedge resection (EAWR), classic LECS and modified LECS. Several studies both domestic and international have shown LECS has advantages in treating various gastrointestinal tumours, but standardised procedures for early gastric cancer are not yet established, and current data is largely from retrospective studies, lacking high-quality prospective evidence.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shandong
      • Qingdao、Shandong、中国、266000
        • Qingdao University Affiliated Hospital West Coast Campus

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age 18-80, any gender;
  2. Gastric adenocarcinoma confirmed by gastroscopic biopsy, with a single lesion;
  3. Clinical staging cT1N0M0 based on enhanced CT, endoscopic ultrasound and other imaging evaluations (tumour limited to the mucosa or submucosa with no evidence of lymph node or distant metastasis);
  4. Absolute indications for endoscopic submucosal dissection (ESD), with lesions no larger than 5cm, or cases where endoscopic removal is difficult. Absolute indications for ESD (differentiated carcinoma, mucosal T1a stage, without ulcer ≤2 cm or with ulcer ≤3 cm; undifferentiated carcinoma without ulcer ≤2 cm. Difficult cases for endoscopic removal: negative "lifting sign", laterally spreading tumours and scar ulcers etc.);
  5. Meets eCURA score criteria for non-curative ESD requiring additional surgery;
  6. ECOG performance status 0-1;
  7. Patient fully informed and consents, signing the consent form. Note: For inclusion, meeting either criterion ④ or ⑤ is sufficient.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Those with a history of major upper abdominal surgery where severe abdominal adhesions are expected;
  3. Patients with recurrent gastric cancer, multiple primary tumours, or those who have undergone preoperative chemoradiotherapy;
  4. Those meeting ESD indications and having completed curative endoscopic resection according to eCURA standards [12,13];
  5. Patients with other unresectable malignant tumours;
  6. Those with severe heart, lung, liver, or kidney dysfunction who cannot tolerate general anaesthesia and surgery;
  7. Those allergic to indocyanine green (ICG) or nano carbon tracers;
  8. Those with mental illness who cannot cooperate with the study and follow-up.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Perform a combined surgery using both microscopes
  1. Inject the fluorescent dye under the endoscope to mark the lesion.
  2. Remove the sentinel lymph node area highlighted by fluorescence after 15 minutes.
  3. If no lymph node metastasis is found in the sentinel lymph node area (SLNB negative), perform a combined double-scope local gastrectomy (endoscopic combined with laparoscopic local gastrectomy or a modified procedure), completely remove the primary lesion, and ensure negative margins.
  4. The local excision specimen should be fully spread and fixed within 20-30 minutes after removal, and sliced continuously at 2 mm intervals. The pathological report needs to include key information such as tissue type, depth of infiltration, margins and vascular invasion.
  5. Postoperative patients are managed according to the standard postoperative pathway. Follow-ups are done at 1, 3, 6, 12, 24, and 36 months after surgery, and then annually, including physical exams, tumour marker tests, imaging checks, and quality of life questionnaires.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Postoperative complications within 30 days after surgery
大体时间:Within 30 days after surgery
Within 30 days after surgery
Overall survival (OS)
大体时间:1 year and 3 years after surgery
1 year and 3 years after surgery
disease-free survival (DFS)
大体时间:1 year and 3 years after surgery
1 year and 3 years after surgery
Local recurrence rate (LR)
大体时间:1 year and 3 years after surgery
1 year and 3 years after surgery

次要结果测量

结果测量
大体时间
Sentinel lymph node prediction accuracy (sensitivity, specificity, etc.)
大体时间:Up to two weeks after surgery (confirmed by paraffin pathology)
Up to two weeks after surgery (confirmed by paraffin pathology)
Sentinel lymph node tracing success rate
大体时间:At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
At most, no more than 2 hours after receiving the specimen for frozen biopsy (intraoperative sentinel lymph node frozen pathology)
R0 resection rate
大体时间:Up to two weeks after surgery(confirmed by paraffin pathology)
Up to two weeks after surgery(confirmed by paraffin pathology)
EORTC QLQ-C30/STO22 scale scores(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30)
大体时间:Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
Before the surgery, and at 3, 6, 12 months after, and 2, 3 years post-surgery
Weight and Body Mass Index
大体时间:Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Albumin and haemoglobin(g/L)
大体时间:Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
NRS2002 Nutrition Risk Screening
大体时间:Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after
Before the surgery, and then 1, 3, 6, 12 months and 2, 3 years after

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年6月28日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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