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Clinical Trials in South Korea / NCT05978882
Starting soon Not applicable

Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)

NCT05978882 · tracked via the Priya Life Science South Korea tracker
Sponsor
National Cancer Center, Korea
Phase
Not applicable
Started
2023-08-17
Last updated
2023-08-07

Condition(s) studied

Early Gastric Cancer

Investigational drug(s) / intervention(s)

Laparoscopic sentinel navigation surgery using fluorescence

Laparoscopic sentinel navigation surgery using fluorescence: If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed

Study 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 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Dongnam Inst. of Radiological & Medical Science Busan Gijang-gun
Gyeongsang National University Hospital Gyeongsang Gingu-si
Sevrance Hospital Seoul Sinchon
Ajou University Medical Center Gyeonggi-do Suwon-si
Gyeongsang National University Changwon Hospital Changwon South Korea
Samsung Medical Center Seoul South Korea
Soon Chun Hyang University Hospital Bucheon Seoul South Korea

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Other trials for the same condition

Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD Active, not recruiting
Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients Recruiting
Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05978882 on ClinicalTrials.gov ↗ ← All trials in South Korea