Clinical trial NCT06748742: A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging
Official title: A Randomized Controlled Trial to Improve the Therapeutic Effect of Robot-assisted Radical Prostatectomy (RARP) Using Indocyanine Green Fluorescence Imaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate CA
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet all the inclusion criteria and have no exclusion criteria for any of the conditions

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: The study subjects completed the follow-up results of 6 months after RARP
timeFrame: One month, three months, six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References: