NCT05978882Not yet recruiting
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 · Last updated 7 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 203 (estimated)
- First submitted
- 20 Jul 2023
- Start date
- 17 Aug 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- National Cancer Center, Korea
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05978882
What you commit to
- Study type: Interventional
- Planned participants: 203
- From 17 Aug 2023 to the primary completion date, 31 Dec 2025
- 7 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
- indication of endoscopic submucosal resection
- having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
Other illness
- inoperable due to poor cardiac, and pulmonary function
- diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Other
- pregnant
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongnam Inst. of Radiological & 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 |
| Ajou University Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Gyeongsang | South Korea | Unknown status |
| Sevrance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Soon Chun Hyang University Hospital Bucheon Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.