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

National Cancer Center, Korea243 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

243

Conditions

Sentinel Lymph Node

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (9)

Bang Wool Eom

Goyang-si, Gyeonggi-do, South Korea

Soonchunhyang University College of Medicine

Bucheon-si, South Korea

Dongnam Institute of Radiological and Medical Science

Busan, South Korea

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Kyungpook National University Medical Center

Daegu, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

Samsung Medical Center

Seoul, South Korea

Ajou University School of Medicine

Suwon, South Korea

Outcomes

Primary Outcomes

detection rate (%)

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

Time frame: 15 days after operation

Secondary Outcomes

False negative rate

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