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A prospective randomized controlled study on the effect of holographic imaging navigation-guided intraoperative frozen section technology for reducing positive surgical margins in robotic-assisted radical prostatectomy

A prospective randomized controlled study on the effect of holographic imaging navigation-guided intraoperative frozen section technology for reducing positive surgical margins in robotic-assisted radical prostatectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063525
Enrollment
Unknown
Registered
2022-09-09
Start date
2022-09-09
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

study group:

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old and = 1(PI-RADS v2 score >= 3), and at least one target lesion is confirmed to be prostate cancer by transperineal targeted biopsy(± systematic biopsy); 4. The distance between the positive target lesion and the lateral posterior capsule or apex or bottom of the prostate is <= 5mm (measured on prostate MRI); 5. The clinical T stage is T1-T2c, and there is no distant metastasis (M0); 6. No obvious contraindications to surgery or general anesthesia; 7. Willing to undergo RARP, and can receive a regular check, evaluations, and follow-up after surgery. 8. Those who signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiopulmonary and other related diseases, unable to tolerate robot-assisted laparoscopic surgery; 2. No target lesions on prostate MRI; 3. The distance from the target lesion to the lateral posterior capsule or tip or bottom of the prostate was > 5mm on prostate MRI; 4. No prostate MRI before surgery; 5. Received neoadjuvant deprivation therapy or chemotherapy for prostate cancer before surgery; 6. Investigators deem it inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
positive surgical margin;

Countries

China

Contacts

Public ContactWang Xuan

Beijing Hospital

alex.wxuan@hotmail.com+86 15201499317

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026