Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000314426
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
16/04/2025
Date last updated
16/04/2025
Date data sharing statement initially provided
16/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, double-blinded, randomised study comparing 16g automated full-core and side-notch biopsy needles for percutaneous renal biopsies in renal transplant patients.
Scientific title
A prospective, double-blinded, randomised study comparing the quality of samples and safety of 16g automated full-core and side-notch biopsy needles for percutaneous renal biopsies in renal transplant patients
Secondary ID [1] 314054 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Transplant 336801 0
Condition category
Condition code
Renal and Urogenital 333294 333294 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protocol biopsies of post-transplant kidneys are a safe and important tool in the detection and management of subclinical rejection which is a relatively common and treatable cause of transplant failure. The standard of care, ‘surveillance’, protocol biopsies are performed at 3 and 12 months post-transplant. This minimally invasive procedure is done under ultrasound guidance to ensure precision and safety by a qualified radiologist. Renal transplant patients referred to the Radiology Department for standard of care renal biopsies will be recruited into the study. Standard of care biopsy procedure and follow-up of patients will be conducted during the trial. The patient will be randomised to which needle will be used in the procedure, automated 16g full core or side-notch needles.
Side-notch biopsy needle is a spring-loaded, automatic biopsy system. It features a two-stage release mechanism: the first stage advances the stylet to position the sample notch within the target tissue, and the second stage fires the cutting cannula over the stylet to capture the tissue sample.
Full-core biopsy needles is also a spring-loaded, automatic biopsy system, designed to cut a full core of tissue, providing large specimens for pathological examination. The system operates using a single pincer mechanism that extends from the cannula to cut and separate the tissue sample.
The two needle types have a similar safety profile and approved for use at The Alfred Hospital, the location of the study. All clinicians performing renal biopsy are knowledgeable, trained and competent to use both needles for renal biopsies. Typically, two to three core tissue samples are collected to ensure an adequate specimen for histological examination. Histology staff will be on procedure site to ascertain the quality of sample.
Intervention code [1] 330702 0
Diagnosis / Prognosis
Comparator / control treatment
16g automated full-core.
Full-core biopsy needles is also a spring-loaded, automatic biopsy system, designed to cut a full core of tissue, providing large specimens for pathological examination. The system operates using a single pincer mechanism that extends from the cannula to cut and separate the tissue sample.
Control group
Active

Outcomes
Primary outcome [1] 340870 0
Biopsy sample yield
Assessment method [1] 340870 0
The number of passes during will be assessed during the renal biopsy procedure and will be document in the procedure report. The sample percentage of cortex, number of glomeruli, and number of arteries are collectively assessed as a composite primary outcome to evaluate biopsy sample yield in renal biopsy procedures and will be recorded in the histology report.
Timepoint [1] 340870 0
Number of pass will be noted during renal biopsy procedure, all other components assessed via histology report provided within 7 days post biopsy.
Secondary outcome [1] 445305 0
Safety
Assessment method [1] 445305 0
Adverse events and complication rate will be assed as a composite secondary outcome to evaluate the safety of biopsy needles used in the study. Procedure related serious adverse events will be reported to The Alfred Ethics Committee within 72 hours of the event or of knowledge of the event. Significant safety issues (SSI) are not anticipated as the safety profile of both needles is well established and both have TGA approval; SSIs will be reported to The Alfred Hospital Ethics Committee within 72 hours. The researchers will be responsible for assessing adverse events, patient care and determining if the study can be continued.
Timepoint [1] 445305 0
During renal biopsy procedure, immediately after procedure, 24 hours post procedure

Eligibility
Key inclusion criteria
Adult renal transplant patients referred for renal biopsy
Normal or corrected coagulation profile
Normal or corrected platelet count
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18,
Native renal biopsy

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/04/2022
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
180
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318560 0
Hospital
Name [1] 318560 0
Alfred Health
Country [1] 318560 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Country
Australia
Secondary sponsor category [1] 320960 0
Other Collaborative groups
Name [1] 320960 0
Radiology Research Unit, The Alfred
Country [1] 320960 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317160 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317160 0
Ethics committee country [1] 317160 0
Australia
Date submitted for ethics approval [1] 317160 0
16/12/2021
Approval date [1] 317160 0
05/04/2022
Ethics approval number [1] 317160 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 140206 0
Dr Bruno Di Muzio
Address 140206 0
The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
Country 140206 0
Australia
Phone 140206 0
+61 03 9076 2126
Email 140206 0
b.dimuzio@alfred.org.au
Contact person for public queries
Name 140207 0
Bruno Di Muzio
Address 140207 0
The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
Country 140207 0
Australia
Phone 140207 0
+61 03 9076 2126
Email 140207 0
b.dimuzio@alfred.org.au
Contact person for scientific queries
Name 140208 0
Bruno Di Muzion
Address 140208 0
The Alfred Hospital, 55 Commercial Road, Victoria, Melbourne 3004
Country 140208 0
Australia
Phone 140208 0
+61 03 9076 2126
Email 140208 0
b.dimuzio@alfred.org.au

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.