The verify the accuracy for sentinel lymph node for endometrial cancer(The verify the accuracy for sentinel lymph node for endometrial cancer)

JRCT ID: jRCTs061200004

Registered date:25/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Endometrial cancer
• Date of first enrollment: 16/10/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Indocyanine g reen 25mg for injection is dissolved in 5ml of water for injection, and usually 5ml or less is divided into cervical local injections as appropriate. During treatment, indocyanine g reen is injected once before surg ery.

Outcome(s)

Primary Outcome

False neg ative rate of sentinel lymph node biopsy with
indocyanine g reen in endometrial cancer

Secondary Outcome

1. Adverse events in indocyanine g reen
2. Incidence of lymphedema

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Female

Include criteria

1.Patients who can obtain written consent from their own
involuntary research participation
2. Patients with histolog ically confirmed endometrial cancer.
3. Patients who have been confirmed by pelvic MRI examination and/or abdominal /pelvic CT examination as preoperative
examination and no patholog ical enlarg ement of lymph nodes
4. Patients scheduled for robot-assisted surg ery for endometrial cancer malig nant tumor
5. Patients ag e 20 to 70 years at the time of reg istration
6. Patients whose g eneral status is 0 or 1
7. Patients with no previous history of radiation therapy, chemotherapy, or surg ery
8.Patients with major org an functions Neutrophil count 2000 / mm3 or more , Hemog lobin 10g / dl or more (correction by
blood transfusion is permitted) , Platelet count 100,000 / mm
3 or more , Total bilirubin 1.5mg / dl AST (GOT) and ALT (GPT) 100 IU / l or lessSerum creatinine 1.2mg / dl or less
9. The following tests must be performed within 28 days prior to the operation,The ECG test should not show normal, and abnormal finding s requiring treatment.

Exclude criteria

1.Patients with active double cancer (simultaneous double
cancer and metachronous double cancer with a disease-free
period of 5 years or less). However, lesions equivalent to intraepithelial cancer or intramucosal cancer that are judg ed to be cured by local treatment are not included in active double
cancer.
2. Patients with a history of indocyanine g reen sensitivity or
iodine sensitivity
3. Patients with severe obesity
4.Patients who are considered difficult to participate in the
study due to complications of heart disease and g laucoma
5. Lactating patients

Related Information

• Primary Sponsor: Nakamura Keiichiro