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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| puncture stent-assisted transperineal prostate biopsy | Experimental | This group of patients underwent puncture stent-assisted transperineal prostate biopsy. |
|
| transperineal free-hand biopsy | Active Comparator | This group of patients underwent perineal free-hand biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| puncture stent-assisted transperineal prostate biopsy | Other | Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| positive rate of biopsy | Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy complications include (infection, bleeding, etc.) | Biopsy complications include (infection, bleeding, etc.) | 1 year |
| Pain score of biopsy patients (NRS score) | Pain score of biopsy patients (NRS score) |
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Inclusion Criteria:
Suspected prostate cancer patients Can tolerate prostate puncture
Exclusion Criteria:
Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shouzhen Chen, Dr. | Contact | 18560089085 | chensz@mail.sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital | Recruiting | Jinan | Shandong | 276600 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
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Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method
| 1 year |
| Biopsy time | Biopsy time | 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |