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ClinicalTrials.gov ID

NCT05978882

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

203Estimated

Last Update Posted

Aug 7, 2023Actual

Start Date

Aug 17, 2023Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2030Estimated

Official Title

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

Brief 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.

• Early Gastric Cancer

• Laparoscopic sentinel navigation surgery using fluorescence

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Ajou University School of MedicineOTHER

Chonnam National University HospitalOTHER

Dongnam Institute of Radiological & Medical SciencesOTHER

Gyeongsang National University HospitalOTHER

Gyeongsang National University Changwon HospitalOTHER

Samsung Medical CenterOTHER

Severance HospitalOTHER

Soon Chun Hyang UniversityOTHER

jar319.an@samsung.com