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Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection — SENORITA2  

Sentinel Lymph Node Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

Sentinel basin dissection method 1. endoscopic tracer injection after general anesthesia 2. Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar 3. Sentinel basin identification with laparoscopic probe 4. Dissection of the sentinel basin 5. Sentinel node dissection at back table 6. Conventional laparoscopic gastrectomy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03123042
Study type Interventional
Source National Cancer Center, Korea
Contact Bang Wool Eom, MD, PhD
Phone 82-31-920-1689
Email kneeling79@ncc.re.kr
Status Recruiting
Phase N/A
Start date March 20, 2017
Completion date December 31, 2024
View Details
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