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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Cancer Center, Korea

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Laparoscopic sentinel navigation surgery using fluorescence

    Procedure/Surgery

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

Treatment groups

203 Participants
are divided into 1 treatment group
Group A: Laparoscopic sentinel navigation surgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Detection rate of Sentinel lymph nodes

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

Time frame
15 days after operation

Secondary outcomes

1

3 year disease free survival

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

Time frame
3 year after surgery
2

3 year overall survival rate

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

Time frame
3 year after surgery
3

3 year disease specific death rate

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

Time frame
3 year after surgery
4

3 year recurrence free survival rate

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

Time frame
3 year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center, Korea

Lead sponsor

Ajou University School of Medicine

Collaborator

Chonnam National University Hospital

Collaborator

Dongnam Institute of Radiological & Medical Sciences

Collaborator

Gyeongsang National University Hospital

Collaborator

Gyeongsang National University Changwon Hospital

Collaborator

Samsung Medical Center

Collaborator

Severance Hospital

Collaborator

Soon Chun Hyang University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: