Clinical trial NCT05978882: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
Official title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Gastric Cancer
Keywords: Early gastric cancer
Sentinel lymph node
Fluorescence
Stomach-preserving surgery
Quality of life
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Ajou University School of Medicine
name: Chonnam National University Hospital
name: Dongnam Institute of Radiological & Medical Sciences
name: Gyeongsang National University Hospital
name: Gyeongsang National University Changwon Hospital
name: Samsung Medical Center
name: Severance Hospital
name: Soon Chun Hyang University
First posted: 2023-08-07
Enrollment: 203
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Detection rate of Sentinel lymph nodes
timeFrame: 15 days after operation
Secondary outcomes:
measure: 3 year disease free survival
timeFrame: 3 year after surgery
measure: 3 year overall survival rate
timeFrame: 3 year after surgery
measure: 3 year disease specific death rate
timeFrame: 3 year after surgery
measure: 3 year recurrence free survival rate
timeFrame: 3 year after surgery
measure: 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
timeFrame: 5 years
measure: 5 year disease free survival rate
timeFrame: 5 years
measure: 5 year overall survival rate
timeFrame: 5 years
measure: 5 year disease specific death rate
timeFrame: 5 years
measure: 5 year recurrence free survival rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongnam Inst. of Radiological & Medical Science
state: Gijang-gun
city: Gyeongsang
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gingu-si
city: Seoul
country: Korea, Republic of
facility: Sevrance Hospital
state: Sinchon
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Medical Center
state: Suwon-si
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
Study officials:
References: