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NCT Number: NCT05978882

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

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.

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Key information

Conditions

Early Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongnam Inst. of Radiological & Medical Science, Busan, Gijang-gun, South Korea

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About this study

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sentinel navigation surgery using fluorescence

Procedure

If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed

Primary outcomes

  1. Detection rate of Sentinel lymph nodes

    Time frame: 15 days after operation

    number of patients whose sentinel nodes are detected / enrolled number of patients *100

Secondary outcomes

  1. 3 year disease free survival

    Time frame: 3 year after surgery

    A total of enrollment period is suspected to be three years and patients will be followed up for five years.

  2. 3 year overall survival rate

    Time frame: 3 year after surgery

    A total of enrollment period is suspected to be three years and patients will be followed up for five years.

  3. 3 year disease specific death rate

    Time frame: 3 year after surgery

    A total of enrollment period is suspected to be three years and patients will be followed up for five years.

  4. 3 year recurrence free survival rate

    Time frame: 3 year after surgery

    A total of enrollment period is suspected to be three years and patients will be followed up for five years.

  5. 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

    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.

  6. 5 year disease free survival rate

    Time frame: 5 years

    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

  7. 5 year overall survival rate

    Time frame: 5 years

    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

  8. 5 year disease specific death rate

    Time frame: 5 years

    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

  9. 5 year recurrence free survival rate

    Time frame: 5 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Man Yoon, MD

CONTACT

[email protected]

+82-31-920-1710

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Ajou University School of Medicine
  • Chonnam National University Hospital
  • Dongnam Institute of Radiological & Medical Sciences
  • Gyeongsang National University Changwon Hospital
  • Gyeongsang National University Hospital
  • Samsung Medical Center
  • Severance Hospital
  • Soon Chun Hyang University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Aug 7, 2023
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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