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

National Cancer Center (NCC)

Status: Not yet enrolling

Conditions: Early Gastric Cancer

Treatments: Procedure: Laparoscopic sentinel navigation surgery using fluorescence

Study type: Interventional

Funder types: Other

Identifiers

NCT05978882

NCC2023-0145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

Laparoscopic sentinel navigation surgery

Experimental group

Description:

compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial)

Treatment:

Procedure: Laparoscopic sentinel navigation surgery using fluorescence