Status:
NOT_YET_RECRUITING
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Ajou University School of Medicine
Chonnam National University Hospital
Conditions:
Early Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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 isotop...
Detailed Description
1. Injection of Indocyanine Green (ICG) * Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer * Identification of sentinel basin using fluorescence laparoscopy * Laparo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT05978882
Start Date
August 17 2023
End Date
December 31 2030
Last Update
August 7 2023
Active Locations (7)
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1
Dongnam Inst. of Radiological & Medical Science
Busan, Gijang-gun, South Korea, 46033
2
Gyeongsang National University Hospital
Gyeongsang, Gingu-si, South Korea, 52727
3
Sevrance Hospital
Seoul, Sinchon, South Korea, 03722
4
Ajou University Medical Center
Gyeonggi-do, Suwon-si, South Korea, 16499