Trial Title:
Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
NCT ID:
NCT05978882
Condition:
Early Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
Early gastric cancer
Sentinel lymph node
Fluorescence
Stomach-preserving surgery
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic sentinel navigation surgery using fluorescence
Description:
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence,
stomach-preserving surgery is performed
Arm group label:
Laparoscopic sentinel navigation surgery
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.
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
- 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongnam Inst. of Radiological & Medical Science
Address:
City:
Busan
Zip:
46033
Country:
Korea, Republic of
Facility:
Name:
Gyeongsang National University Hospital
Address:
City:
Gyeongsang
Zip:
52727
Country:
Korea, Republic of
Facility:
Name:
Sevrance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Ajou University Medical Center
Address:
City:
Gyeonggi-do
Zip:
16499
Country:
Korea, Republic of
Facility:
Name:
Gyeongsang National University Changwon Hospital
Address:
City:
Changwon
Zip:
51472
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
Ji Yeong An
Email:
jar319.an@samsung.com
Facility:
Name:
Soon Chun Hyang University Hospital Bucheon
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
In Jo
Start date:
August 17, 2023
Completion date:
December 31, 2030
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Collaborator:
Agency:
Ajou University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Chonnam National University Hospital
Agency class:
Other
Collaborator:
Agency:
Dongnam Institute of Radiological & Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Gyeongsang National University Hospital
Agency class:
Other
Collaborator:
Agency:
Gyeongsang National University Changwon Hospital
Agency class:
Other
Collaborator:
Agency:
Samsung Medical Center
Agency class:
Other
Collaborator:
Agency:
Severance Hospital
Agency class:
Other
Collaborator:
Agency:
Soon Chun Hyang University
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978882
