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

NCT ID: NCT05179720

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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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 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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method

Study Groups

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puncture stent-assisted transperineal prostate biopsy

This group of patients underwent puncture stent-assisted transperineal prostate biopsy.

Group Type EXPERIMENTAL

puncture stent-assisted transperineal prostate biopsy

Intervention Type OTHER

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

transperineal free-hand biopsy

This group of patients underwent perineal free-hand biopsy

Group Type ACTIVE_COMPARATOR

puncture stent-assisted transperineal prostate biopsy

Intervention Type OTHER

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

Interventions

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puncture stent-assisted transperineal prostate biopsy

Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shouzhen Chen, Dr.

Role: CONTACT

18560089085

Facility Contacts

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shouzhen chen

Role: primary

18560089085

Other Identifiers

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CSZ02

Identifier Type: -

Identifier Source: org_study_id

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