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Trial registered on ANZCTR


Registration number
ACTRN12620000132943p
Ethics application status
Submitted, not yet approved
Date submitted
30/12/2019
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between two methods for teaching the procedure of renal biopsy
Scientific title
Comparison between freehand and needle guide techniques for the teaching of percutaneous renal biopsy in medical trainees: a randomised control trial
Secondary ID [1] 300082 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal biopsy methods
 315706 0
Condition category
Condition code
Renal and Urogenital 313993 313993 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is designed to compare the two methods of performing renal biopsy - either using an ultrasound probe needle guide or freehand - for the teaching of junior doctors. The intervention will be the use of the ultrasound probe needle guide. This will be performed on a simulation mannequin.
The training to use the ultrasound probe needle guide will be in the form of a single 15 minute presentation including video demonstration. This demonstration will undertaken by a renal physician experienced in the skill of renal biopsy. The ultrasound imaging of each attempt at the procedure will be video recorded.
Intervention code [1] 316437 0
Treatment: Devices
Comparator / control treatment
The control group will learn the skill of renal biopsy without the use of an ultrasound probe needle guide, otherwise called the "freehand" group. This will be performed on a simulation mannequin.
The training to perform a "freehand" renal biopsy will be in the form of a single 15 minute presentation including video demonstration. This demonstration will undertaken by a renal physician experienced in the skill of renal biopsy. The ultrasound imaging of each attempt at the procedure will be video recorded.
Control group
Active

Outcomes
Primary outcome [1] 322399 0
To compare the needle guide technique and freehand technique in the domains of safety and adequacy for teaching novice operators the procedure of real-time ultrasound guided renal biopsy. This will be a composite endpoint comprising of
- Proportion of passes in which the core is taken of the lower pole (must be 100% to be deemed safe), as assessed by the observer on ultrasound imaging, and then checked independently by reviewing video footage of the ultrasound imaging,
- Proportion of passes in which the biopsy needle and ultrasound are simultaneously visualised at time of biopsy (must be 100% to be deemed safe), as assessed by the observer on ultrasound imaging, and then checked independently by reviewing video footage of the ultrasound imaging,
- Proportion of passes that successfully obtain a core of renal tissue (determined macroscopically) (must successfully biopsy kidney in at least 2 of 3 passes)
Timepoint [1] 322399 0
Immediately post intervention
Secondary outcome [1] 378328 0
To compare the proportion of passes that successfully biopsied kidney between the freehand and needle guide groups as assessed by the observer on ultrasound imaging, and then checked independently by reviewing video footage of the ultrasound imaging,
Timepoint [1] 378328 0
Immediately post intervention
Review completed within 1 week of intervention
Secondary outcome [2] 379785 0
To compare the rate of continuous visualisation of both the kidney and biopsy needle in the needle guide technique and freehand technique groups as assessed by the observer on ultrasound imaging, and then checked independently by reviewing video footage of the ultrasound imaging,
Timepoint [2] 379785 0
Immediately post intervention
Review completed within 1 week of intervention
Secondary outcome [3] 379786 0
To compare the time taken to complete 3 cores between the
needle guide technique and freehand technique as assessed by the observer using a stopwatch.
Timepoint [3] 379786 0
Immediately post intervention
Secondary outcome [4] 379787 0
To compare the time taken (using a stopwatch) to adequately visualise the kidney between the
needle guide technique and freehand technique as assessed by the observer on ultrasound imaging
Timepoint [4] 379787 0
Immediately post intervention
Secondary outcome [5] 379788 0
To compare the subjective difficulty as graded by the participant of learning the skill of percutaneous renal biopsy using freehand or ultrasound needle guide method using a visual analogue scale
Timepoint [5] 379788 0
Within 1 hour of completing intervention
Secondary outcome [6] 379789 0
To compare the subjective difficulty as graded by the assessor of performing percutaneous renal biopsy using freehand or ultrasound needle guide as assessed using a visual analogue scale
Timepoint [6] 379789 0
Immediately post intervention

Eligibility
Key inclusion criteria
Over the age of 18 years
Current medical student, intern, RMO or Basic Physician Trainee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unwilling to consent
Previous significant experience in performing or simulation of renal biopsy

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This trial will be analysed as an intention to treat analysis. Given the primary outcome is dichotomous, chi squared or binomial logistic regression will be used depending on the variability of the remainder of the data.

Other categorical data will be compared using Persons chi quared. Data that is normally distributed will be analysed with parametric tests and non-normally distributed data will be analysed with non-parametric tests. Significance will be set at 0.05 and adjustments for multiple comparisons will be made where comparing several groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15562 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 28936 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 304529 0
Hospital
Name [1] 304529 0
Liverpool Hospital Renal Unit
Country [1] 304529 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street, Liverpool, NSW 2170.
Country
Australia
Secondary sponsor category [1] 304800 0
None
Name [1] 304800 0
Address [1] 304800 0
Country [1] 304800 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304961 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304961 0
Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871
Ethics committee country [1] 304961 0
Australia
Date submitted for ethics approval [1] 304961 0
16/01/2020
Approval date [1] 304961 0
Ethics approval number [1] 304961 0

Summary
Brief summary
Kidney biopsy is an important test to diagnose and monitor many kidney conditions. It is performed with ultrasound to allow continuous vision of the biopsy needle passing into the kidney. This requires the operator to hold the ultrasound probe with one hand whilst manipulating the biopsy needle with the other, which can be difficult for newcomers. A needle guide attached to the ultrasound probe ensures the needle and ultrasound probe are always aligned to provide optimal images of both the kidney and needle simultaneously.

Junior doctors will be randomly assigned to perform an ultrasound guided kidney biopsy in a synthetic model, with or without the aid of a needle guide. The impact of the needle guides will be assessed according to safety and adequacy as well as user feedback, to determine which method is superior for teaching this skill to junior doctors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98774 0
Dr Elizabeth Downie
Address 98774 0
Liverpool Hospital
Elizabeth Street,
Liverpool, NSW, 2170.
Country 98774 0
Australia
Phone 98774 0
+61 421523773
Fax 98774 0
Email 98774 0
[email protected]
Contact person for public queries
Name 98775 0
Elizabeth Downie
Address 98775 0
Liverpool Hospital
Elizabeth Street,
Liverpool, NSW, 2170.
Country 98775 0
Australia
Phone 98775 0
+61 421523773
Fax 98775 0
Email 98775 0
[email protected]
Contact person for scientific queries
Name 98776 0
Elizabeth Downie
Address 98776 0
Liverpool Hospital
Elizabeth Street,
Liverpool, NSW, 2170.
Country 98776 0
Australia
Phone 98776 0
+61 421523773
Fax 98776 0
Email 98776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6279Study protocol    378929-(Uploaded-30-12-2019-16-24-27)-Study-related document.docx



Results publications and other study-related documents

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Documents added automatically
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