Clinical trial · Interventional
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
- 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)
SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic sentinel navigation surgery using fluorescence | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic sentinel navigation surgery
- description
- compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)
- interventionNames
- Procedure: Laparoscopic sentinel navigation surgery using fluorescence
Primary outcomes (1)
- measure
- Detection rate of Sentinel lymph nodes
- timeFrame
- 15 days after operation
- description
- number of patients whose sentinel nodes are detected / enrolled number of patients \*100
Secondary outcomes (9)
- measure
- 3 year disease free survival
- timeFrame
- 3 year after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography * tumor size: less than 3cm * location: 2cm far from the pylorus or cardia * aged 20 to 80 * ECOG 0 or 1 * patient who signed the agreement * patient who is suspected to underwent laparoscopic or robotic gastrectomy Exclusion Criteria: * indication of endoscopic submucosal resection * inoperable due to poor cardiac, and pulmonary function * pregnant * having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen * diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
References
Publications (0)
Data not yet available