NCT03123042

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Sentinel Lymph Node
• Early Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Sentinel basin dissection	Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy

Timeline

• Start date: 2017-03-20
• Primary completion: 2024-11-21
• Completion: 2024-12-31
• First posted: 2017-04-21
• Last updated: 2025-04-02

Locations

9 sites across 1 country: South Korea