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Not yet recruiting NCT05978882

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

No phase Interventional Early Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic sentinel navigation surgery using fluorescence.
Who it may be relevant to
Registry conditions: Early Gastric Cancer. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Detection rate of Sentinel lymph nodes [Time frame: 15 days after operation]
Secondary outcome measures (9)
  • 3 year disease free survival [Time frame: 3 year after surgery]
  • 3 year overall survival rate [Time frame: 3 year after surgery]
  • 3 year disease specific death rate [Time frame: 3 year after surgery]
  • 3 year recurrence free survival rate [Time frame: 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 [Time frame: 5 years]
  • 5 year disease free survival rate [Time frame: 5 years]
  • 5 year overall survival rate [Time frame: 5 years]
  • 5 year disease specific death rate [Time frame: 5 years]
  • 5 year recurrence free survival rate [Time frame: 5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 7 centers
  • Dongnam Inst. of Radiological & Medical Science — Busan
  • Gyeongsang National University Hospital — Gyeongsang
  • Sevrance Hospital — Seoul
  • Ajou University Medical Center — Gyeonggi-do
  • Gyeongsang National University Changwon Hospital — Changwon
  • Samsung Medical Center — Seoul
  • Soon Chun Hyang University Hospital Bucheon — Seoul

Identifiers

NCT: NCT05978882 · NCC2023-0145

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗