A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging

In Robotic Assistant Radical Prostatectomy (RARP), indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Prostate CA

Age range

18 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with prostate cancer who underwent robot-assisted radical prostatectomy at Shanghai First People's Hospital Patients with naïve localized prostate cancer or locally advanced prostate cancer The patient > 18 years and < 85 years Before the surgery, the prostate MR scan sagittal view of the prostate in our hospital measured the separation of the bladder neck < 1cm The patient underwent robot-assisted laparoscopic radical resection of the prostate malignancy in our hospital with anterior approach The patient returned to normal after surgery, and there were no postoperative complications such as intestinal obstruction that affected the patient's blood routine and biochemical indicators

Exclusion criteria

Patients with metastatic prostate cancer Patients without preoperative puncture pathology Patients with sagittal bladder neck separation ≥ 1cm of prostate MR non-contrast prostate in our hospital before surgery Patients with preoperative examinations confirming that the enlarged prostate protrudes into the bladder floor Patients with preoperative examination confirming that the lesion is located at the tip of the prostate and near the bladder neck Patients with tumor stage reaching cT4 stage and possible invasion of bladder neck Patients who have undergone adjuvant therapy such as endocrine therapy and radiotherapy before surgery Patients with a history of any prostate surgery other than needle biopsy prior to radical resection of prostate malignancy Patients who have undergone resection of transurethral bladder lesions Patients who have undergone abdominal/pelvic surgery that makes it difficult to separate the prostate and surrounding structures during RARP Patients undergoing extended pelvic lymph node dissection during surgery Patients with posterior approach during surgery Patients with poor urinary continence due to any non-surgical factors after surgery Patients with a history of ICG allergy

Treatment and study plan

In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by the device

Drug

In robot-assisted radical prostatectomy, indocyanine green fluorescent solution is injected through the urethra, and the position and structure of the urethra are observed by using the fluorescence imaging equipment that comes with the device. Guided by real-time fluorescence imaging, the urethra is precisely dissected and severed in front of the bladder neck. Through this improved operation, the bladder neck is protected, the neck injury that is common in conventional surgical operations is reduced, and the reconstructive surgical operations necessary after loss are reduced, and the surgical efficiency is improved. By protecting the bladder neck, the sphincter is better preserved, postoperative urinary incontinence is reduced, and the surgical outcome is improved.

Primary outcomes

The study subjects completed the follow-up results of 6 months after RARP

Time frame: One month, three months, six months after surgery

The resection margins of the postoperative pathology of the patients included in the study and the urinary continence at one, three, and six months follow-up after surgery; Repeat PSA values (to reflect the presence or absence of biochemical recurrence)

Sponsors and collaborators

Lead sponsor

Liu Cheng

Other

Registry information

Acronym: ICG-RARP

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 27, 2024
Registry last updated: Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting