NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031240298

Registered date:26/08/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedProstate Cancer
Date of first enrollment26/08/2024
Target sample size6
Countries of recruitment
Study typeInterventional
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 OutcomeThe 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 Outcome1) 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
GenderMale
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Negoro Hiromitsu
Address 2-1-1 Amakubo, Tsukuba, Ibaraki, Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3223
E-mail hnegoro@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital
Scientific contact
Name Hiromitsu Negoro
Address 2-1-1 Amakubo, Tsukuba, Ibaraki, Japan Ibaraki Japan 305-8576
Telephone +81-29-853-3223
E-mail hnegoro@md.tsukuba.ac.jp
Affiliation University of Tsukuba Hospital