A prospective, double-blinded, randomised study comparing 16g automated full-core and side-notch biopsy needles for percutaneous renal biopsies in renal transplant patients.

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.