Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection

Study Overview
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Brief Summary
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Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients. Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them. The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.

Detailed Description
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Sentinel basin dissection method endoscopic tracer injection after general anesthesia Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar Sentinel basin identification with laparoscopic probe Dissection of the sentinel basin Sentinel node dissection at back table Conventional laparoscopic gastrectomy

Official Title
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Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection

Conditions
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Sentinel Lymph Node, Early Gastric Cancer

Intervention / Treatment
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* Procedure: Sentinel basin dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No limitation for age if the patient is available for gastrectomy Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication. The expanded criteria for endoscopic resection are as follows criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size > 2 cm criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm criterion III: intramucosal tumor without ulcerative findings and of undifferentiated type with size < 2 cm criterion IV, submucosal invasion < 500 mm and of differentiated type with size ≤ 3 cm) Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1 Exclusion Criteria: Inoperative due to severe cardiovascular or pulmonary disease Pregnant Patients who had previous gastric surgery Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel basin dissection<br>Intervention: Sentinel basin dissection | Procedure: Sentinel basin dissection<br>* Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate (%) | number of patients whose sentinel nodes are detected / enrolled number of patients *100 | 15 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate | number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100 | 15 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node, Early gastric cancer, Non-curative endoscopic resection