Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel basin dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel basin dissection
- description
- Intervention: Sentinel basin dissection
- interventionNames
- Procedure: Sentinel basin dissection
Primary outcomes (1)
- measure
- detection rate (%)
- timeFrame
- 15 days after operation
- description
- number of patients whose sentinel nodes are detected / enrolled number of patients \*100
Secondary outcomes (1)
- measure
- False negative rate
- timeFrame
- 15 days after operation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDEom BW, Yoon HM, Min JS, Cho I, Park JH, Jung MR, Hur H, Kim YW, Park YK, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol. J Gastric Cancer. 2019 Jun;19(2):157-164. doi: 10.5230/jgc.2019.19.e12. Epub 2019 Apr 15. PMID 31245160