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

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.

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Key information

Conditions

Sentinel Lymph Node Digestive System Diseases Digestive System Neoplasms Early Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bang Wool Eom, Goyang-si, Gyeonggi-do, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel basin dissection

Procedure

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

Primary outcomes

detection rate (%)

Time frame: 15 days after operation

number of patients whose sentinel nodes are detected / enrolled number of patients *100

Secondary outcomes

False negative rate

Time frame: 15 days after operation

number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Acronym: SENORITA2

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Apr 21, 2017
Registry last updated: Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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