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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978882
• Other study ID #: NCC2023-0145
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2023
• Source: National Cancer Center, Korea
• Contact: Hong Man Yoon, MD
• Phone: +82-31-920-1710
• Email: red10000[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 203
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Ajou University School of Medicine, Chonnam National University Hospital, Dongnam Institute of Radiological & Medical Sciences, Gyeongsang National University Changwon Hospital, Gyeongsang National University Hospital, Samsung Medical Center, Severance Hospital, Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of Sentinel lymph nodes	number of patients whose sentinel nodes are detected / enrolled number of patients *100	15 days after operation
Secondary	3 year disease free survival	A total of enrollment period is suspected to be three years and patients will be followed up for five years.	3 year after surgery
Secondary	3 year overall survival rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years.	3 year after surgery
Secondary	3 year disease specific death rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years.	3 year after surgery
Secondary	3 year recurrence free survival rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years.	3 year after surgery
Secondary	scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22	Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functional scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires.	5 years
Secondary	5 year disease free survival rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years
Secondary	5 year overall survival rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years
Secondary	5 year disease specific death rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years
Secondary	5 year recurrence free survival rate	A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention	5 years