Prostate Cancer Prostate Cancer
Conditions
Interventions
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.
Single-arm, exploratory
Sponsors
Nitta Satoshi
Hiroyuki Nishiyama
Negoro Hiromitsu
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactNegoro Hiromitsu
University of Tsukuba Hospital
Outcome results
None listed