NCT05179720

The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy

Detailed description

This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	puncture stent-assisted transperineal prostate biopsy	Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-01
• Completion: 2023-12-31
• First posted: 2022-01-05
• Last updated: 2022-10-18

Locations

1 site across 1 country: China