Localization of lymph nodes by fluorescent agents in robotic prostate cancer surgery

JRCT ID: jRCTs031240188

Registered date:27/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 27/06/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): ICG injection during robotic surgery.

Outcome(s)

• Primary Outcome: The percentage of pelvic lymphatic pathway (pathway A/B/C etc.) (%)

Secondary Outcome

1) site-specific lymph node ICG staining
2) evaluation of the accuracy of identification of metastatic lymph nodes by ICG
Sensitivity of metastatic lymph nodes
The specificity of metastatic lymph nodes
False-positive rate of metastatic lymph nodes
False-negative rate of metastatic lymph nodes
3) safety evaluation items
Number of adverse events (specific adverse events, number of responses and proportion)

Key inclusion & exclusion criteria

• Age minimum: >= 35age old
• Age maximum: <= 85age old
• Gender: Male

Include criteria

1)Patients with prostate cancer of stage T1-3N0-1M0 who need radical prostatectomy using da Vinci Xi.
2) Age from 35 to 85 years old.
3) PS0-1 (ECOG performance status score)
4) The examination results within three months indicate that the patient can undergo general anesthesia surgery.
5) Obtain written informed consent.

Exclude criteria

1) case of iodine hypersensitivity or a history of drug allergy to a drug to be used (ICG etc.)
2) cases suspected of disseminated disease outside the pelvis
3) cases deemed inappropriate by research responsibility or research sharing physician

Related Information

• Primary Sponsor: Sakamoto Shinichi
• Source(s) of Monetary Support: Chiba University Hospital
• Secondary ID(s): Nil known