Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
- Conditions
- Sentinel Lymph NodeEarly Gastric Cancer
- Interventions
- Procedure: Sentinel basin dissection
- Registration Number
- NCT03123042
- Lead Sponsor
- National Cancer Center, Korea
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 243
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sentinel basin dissection Sentinel basin dissection Intervention: Sentinel basin dissection
- Primary Outcome Measures
Name Time Method detection rate (%) 15 days after operation number of patients whose sentinel nodes are detected / enrolled number of patients \*100
- Secondary Outcome Measures
Name Time Method False negative rate 15 days after operation number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node \*100
Trial Locations
- Locations (9)
Bang Wool Eom
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Soonchunhyang University College of Medicine
🇰🇷Bucheon, Korea, Republic of
Dongnam Institute of Radiological and Medical Science
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Kyungpook National University Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University School of Medicine
🇰🇷Suwon, Korea, Republic of