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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: Laparoscopic sentinel navigation surgery using fluorescence

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.

• Study Type: Interventional
• Enrollment (Estimated): 203
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hong Man Yoon, MD; Phone Number: +82-31-920-1710; Email: red10000@ncc.re.kr

Study Locations

• Korea, Republic of
  • Changwon, Korea, Republic of, 51472
    • Gyeongsang National University Changwon Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
    • Contact: Ji Yeong An; Email: jar319.an@samsung.com
  • Seoul, Korea, Republic of
    • Soon Chun Hyang University Hospital Bucheon
    • Contact: In Jo
  • Gijang-gun
    • Busan, Gijang-gun, Korea, Republic of, 46033
      • Dongnam Inst. of Radiological & Medical Science
  • Gingu-si
    • Gyeongsang, Gingu-si, Korea, Republic of, 52727
      • Gyeongsang National University Hospital
  • Sinchon
    • Seoul, Sinchon, Korea, Republic of, 03722
      • Sevrance Hospital
  • Suwon-si
    • Gyeonggi-do, Suwon-si, Korea, Republic of, 16499
      • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic sentinel navigation surgery; compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of Sentinel lymph nodes	number of patients whose sentinel nodes are detected / enrolled number of patients *100	15 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 17, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Early gastric cancer; Quality of life; Fluorescence; Sentinel lymph node; Stomach-preserving surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: NCC2023-0145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No