Trial to evaluate the assistance of surgery by visualizing the urinary tract using a fluorescent substance called indocyanine green during robot-assisted laparoscopic radical prostatectomy

JRCT ID: jRCTs031240298

Registered date:26/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prostate Cancer
• Date of first enrollment: 23/10/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): A diluted solution of ICG) (2 mg/100 ml) is injected into the urinary tract through a urethral catheter filled with saline, and observed using the da Vinci Firefly Imaging System.

Outcome(s)

Primary Outcome

The surgeon assesses the usefulness of identifying the bladder-prostate separation line during bladder neck dissection. A 5-point Likert scale is used for evaluation (1: Not useful at all, 2: Not very useful, 3: Neutral, 4: Somewhat useful, 5: Very useful).
1 )Is it useful for determining the line to start the bladder neck incision?
2 )Is it useful for determining the bladder-prostate resection line?
3) Is it useful for more accurately preserving the internal urethral orifice?
4) Is it considered overall useful during bladder neck dissection?

Secondary Outcome

1) Time required for bladder neck dissection
2) Safety
3) Usefulness during surgery, such as urethral surrounding dissection (surgeon evaluation)
3-1) Is it a landmark when incising the dorsal vein complex (venous plexus from the penis to the posterior side of the prostate)?
3-2) Is it useful for determining the urethral incision line?
4) Likert scale evaluation by assistants and external evaluators on bladder neck dissection and urethral surrounding dissection
5) Positive rate of bladder neck margin

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 80age old
• Gender: Male

Include criteria

1) Patients diagnosed with primary prostate cancer via histological examination, undergoing robot-assisted radical prostatectomy (RARP).
2) Patients aged between 40 and 80 years at the time of consent acquisition.
3) Patients who have received sufficient explanation about the study, have a thorough understanding, and have provided written consent voluntarily.

Exclude criteria

1) Patients with a history of hypersensitivity to ICG.
2) Patients with a history of iodine hypersensitivity.
3) Patients with cT3
4) Patients with a prostate volume exceeding 100 ml or a prostate protrusion into the bladder of 2 cm or more
5) Patients with a history of pelvic surgery or pelvic radiotherapy
6) Patients with neurogenic bladder
7) Patients deemed inappropriate as subjects by the responsible (participating) investigator.

Related Information

• Primary Sponsor: Negoro Hiromitsu
• Secondary Sponsor: Hiroyuki Nishiyama
• Source(s) of Monetary Support: University of Tsukuba Hospital,Donation "DLMM0002K" (for Education and Research in Department of Urology)