CT-Ultrasound Fusion in Guiding PCNL Puncture

November 25, 2020 updated by: Zhenyu Wu

Accurate Positioning of CT-Ultrasound Fusion in PCNL Puncture Guidance

Kidney stone is a common urological disease. Percutaneous nephrolithotomy (PCNL) is an important method for the treatment of kidney stones. The accuracy of puncture positioning affects the PCNL stone free rate and intraoperative/postoperative complications. Currently, PCNL puncture positioning methods are mainly X-ray-guided or ultrasound-guided. The main disadvantage of X-ray is the lack of soft tissue imaging, and the problem of low puncture accuracy. Although ultrasound is a commonly used real-time imaging tool, the image is not intuitive enough, and the puncture path is deviated from actual requirements . In order to improve the accuracy of PCNL puncture, this study intends to import CT images of both kidneys into a novel ultrasound machine through an image fusion system to achieve CT-ultrasound image fusion, and to simulate the puncture route to guide the PCNL puncture process. The study is mainly divided into two parts: (1) For patients with kidney stones who are planning to undergo PCNL, perform a preoperative simulated CT-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route; (2) Apply CT- Ultrasound fusion precise positioning to guide the intraoperative PCNL puncture process. On the basis of traditional ultrasound images, the CT-ultrasound fusion image display is added to provide the optimal puncture route to explore the effectiveness and safety of CT-ultrasound fusion precise positioning in PCNL puncture.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We plan to enroll 50 patients to explore the effectiveness and safety of CT-ultrasound fusion in guiding PCNL puncture positioning.

Description

Inclusion Criteria:

  • (1) Age ≥18 years old, gender is not limited, and can tolerate surgery; (2) Kidney stone patients who intend to undergo PCNL surgery; (3) Have kidney CT data; (4) Volunteer to participate and sign informed consent.

Exclusion Criteria:

  • (1) Uncontrollable systemic hemorrhagic disease; (2) Severe spinal deformity, severe hip deformity, and difficult lithotomy position; (3) Uncontrolled urinary tract infection; (4) Cavity caused by any urinary system anatomy Internal surgery cannot be performed; (5) Pregnant women, women who plan to become pregnant within 3 months, and lactating women; (6) Patients with severe heart, lung and brain diseases that cannot tolerate surgery; (7) The investigator judges that the patient is not suitable for participating in this study , Including (but not limited to): known to be carrying human immunodeficiency virus or suffering from AIDS; suffering from mental illness; infectious diseases, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CT-Ultrasound group
Device: CT-Ultrasound
For patients with kidney stones who are planning to undergo PCNL, perform a preoperative simulated CT-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route. Apply CT- Ultrasound fusion precise positioning to guide the intraoperative PCNL puncture process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: in a week
Stone free rate in a week
in a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhenyu Wu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

November 25, 2020

First Submitted That Met QC Criteria

November 25, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-KY-021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Stone

Clinical Trials on CT-Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe