NCT03123042Completed
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 243 (actual)
- First submitted
- 10 Apr 2017
- Start date
- 20 Mar 2017
- Primary completion date
- 21 Nov 2024
- Lead sponsor
- National Cancer Center, Korea
- NCT number
- NCT03123042
What you commit to
- Study type: Interventional
- Participants enrolled: 243
- From 20 Mar 2017 to the primary completion date, 21 Nov 2024
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Inoperative due to severe cardiovascular or pulmonary disease
Other
- Pregnant
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soonchunhyang University College of Medicine Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Unknown status |
| Dongnam Institute of Radiological and Medical Science Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Gyeongsang National University Changwon hospital Coordinator of this site? Confirm its status | Changwon | South Korea | Unknown status |
| Kyungpook National University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Bang Wool Eom Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University School of Medicine Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.