Spots Global Cancer Trial Database for Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
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Trial Identification
Brief Title: Feasibility Study of Sentinel Navigation Surgery After Non-curative Endoscopic Resection
Official Title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
Study ID: NCT03123042
Interventions
Study Description
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
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Bang Wool Eom, MD, PhD
Affiliation: National Cancer Center, Korea
Role: PRINCIPAL_INVESTIGATOR
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