Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
NCT ID: NCT05978882
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
203 participants
INTERVENTIONAL
2023-08-17
2030-12-31
Brief Summary
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Detailed Description
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* Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer
* Identification of sentinel basin using fluorescence laparoscopy
* Laparoscopic sentinel basin dissection and identification of sentinel node at the back table
2. Surgical considerations
* Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section.
* If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed.
* However, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Laparoscopic sentinel navigation surgery
compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)
Laparoscopic sentinel navigation surgery using fluorescence
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
Interventions
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Laparoscopic sentinel navigation surgery using fluorescence
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Ajou University School of Medicine
OTHER
Chonnam National University Hospital
OTHER
Dongnam Institute of Radiological & Medical Sciences
OTHER
Gyeongsang National University Hospital
OTHER
Gyeongsang National University Changwon Hospital
OTHER
Samsung Medical Center
OTHER
Severance Hospital
OTHER
Soon Chun Hyang University
OTHER
National Cancer Center, Korea
OTHER_GOV
Responsible Party
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Hong Man Yoon
MD
Locations
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Dongnam Inst. of Radiological & Medical Science
Busan, Gijang-gun, South Korea
Gyeongsang National University Hospital
Gyeongsang, Gingu-si, South Korea
Sevrance Hospital
Seoul, Sinchon, South Korea
Ajou University Medical Center
Gyeonggi-do, Suwon-si, South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Soon Chun Hyang University Hospital Bucheon
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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In Jo
Role: primary
Other Identifiers
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NCC2023-0145
Identifier Type: -
Identifier Source: org_study_id
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