Laparoscopic-endoscopic Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
2026年9月10日 更新者：Dong Yang、Jilin University
A Prospective Registry Study of Laparoscopic-endoscopic Cooperative Surgery Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
This study is to evaluate the safety and efficacy of dual-endoscope assisted sentinel lymph node navigation surgery for early gastric cancer (EGC).
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
36
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。
学习联系方式
- 姓名：Quan Wang, Professor
- 电话号码：15843073207
- 邮箱：wquan@jlu.edu.cn
学习地点
-
-
Jilin
-
Changchun、Jilin、中国、130021
- 招聘中
- The First Hospital of Jilin University
-
接触：
- Quan Wang, Professor
- 电话号码：86-15843073207
- 邮箱：wquan@jlu.edu.cn
-
接触：
-
Ch’ang-ch’un、Jilin、中国、130021
- 主动，不招人
- The First Hospital of Jilin University
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Preoperative assessment indicating that the tumor was confined to the mucosa or submucosa, consistent with the diagnosis of early gastric cancer.
- Patients who required additional surgical intervention following initial endoscopic submucosal dissection (ESD) based on postoperative pathological evaluation.
- Patients and their families fully understood the procedure, requested dual-endoscope assisted sentinel lymph node navigation surgery, agreed to participate in this clinical study, and signed the informed consent form.
Exclusion Criteria:
- Preoperative assessment indicating suspected lymph node or distant metastasis.
- History of complex abdominal surgery rendering laparoscopic treatment infeasible.
- Participation in another clinical trial within 4 weeks prior to enrollment or currently participating in another trial.
- History of severe psychiatric disorders.
- Pregnant or lactating women.
- Uncontrolled infection prior to surgery.
- Presence of other malignancies or comorbidities that may significantly affect survival.
- Any other conditions deemed by the investigators as unsuitable for participation, or refusal by the patient or family to enroll.
- Cardiopulmonary, hepatic, and renal functions were unsufficient to tolerate the surgery.
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：Sentinel Lymph Node Navigation Surgery
Laparoscopic-endoscopic cooperative surgery (LECS) Assisted Sentinel Lymph Node Navigation Surgery for Early Gastric Cancer
|
After preoperative assessment and confirmation of eligibility, patients received general anesthesia with endotracheal intubation.
Indocyanine green (ICG) was injected submucosally around the lesion in four quadrants to trace the sentinel lymph node (SLN) basin.
Laparoscopic marking of the SLN basin was performed.
Endoscopy assisted laparoscopy in marking the primary lesion border (ensuring a margin of >0.5 cm).
Laparoscopic sentinel lymph node dissection was performed, followed by endoscopic/laparoscopic full-thickness resection of the lesion.
Gastric wall defects were closed laparoscopically.
SLNs were harvested and sent for intraoperative frozen section pathology.
If positive, a standard radical gastrectomy was performed; if negative, an abdominal drainage tube was placed to complete the procedure.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of perioperative complications.
大体时间：One month after surgery
|
Postoperative complications comprised hemorrhage, obstruction, gastrointestinal motility disorders, and fistulas.
The overall complication rate was calculated as the number of patients with complications divided by the total number of patients in the cohort.
|
One month after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of retrieved lymph nodes.
大体时间：One week after the surgery.
|
The number of lymph nodes retrieved from all resected specimens.
|
One week after the surgery.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
R0 resection rate
大体时间：One month after surgery.
|
The R0 resection rate was defined as the proportion of patients with histopathologically confirmed complete resection and negative margins among all enrolled patients.
|
One month after surgery.
|
|
Number of patients requiring further therapy
大体时间：Three month after surgery.
|
Number of patients requiring further therapy (e.g., standard radical gastrectomy or chemotherapy).
|
Three month after surgery.
|
|
the number of postoperative hospital stay in days.
大体时间：One month after the surgery.
|
Time from surgery to discharge was recorded in days.
|
One month after the surgery.
|
|
the number of time to first resumption of liquid diet in days
大体时间：One month after surgery.
|
Time to first resumption of liquid diet was recorded in days.
|
One month after surgery.
|
|
the total number of Hospitalization costs in Chinese Yuan (CNY).
大体时间：One month after surgery.
|
Total hospitalization costs were calculated in Chinese Yuan (CNY).
|
One month after surgery.
|
|
the rate of positive cytological examination results of peritoneal lavage fluid.
大体时间：One week after surgery.
|
Cytological examination of the irrigation fluid from the surgical field was performed postoperatively.
A finding of tumor cells was considered positive.
|
One week after surgery.
|
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。
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5月12日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年5月22日
首先提交符合 QC 标准的
2026年5月22日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年9月14日
上次提交的符合 QC 标准的更新
2026年9月10日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.