Cryoablation involves image-guided insertion of single-use specialised needles or probes
through the skin into a soft tissue or bone lesion. A mechanised unit is connected to the
probe(s) and generates cyclical freezing and thawing of the tissues at the probe tip(s)
via exchange of highly pressurised gases through the probe lumen(s), utilising the
Joules-Thomson effect. Extreme freezing and thawing of the lesion causes permanent tissue
destruction through both mechanical disruption of tissue membranes and a secondary immune
response effect.
Cryoablation is one of several minimally invasive ablative techniques used to reduce the
size of or to eradicate soft tissue and bone lesions. Ablative techniques are now an
accepted standard of care for many benign and malignant lesions in adult practice.
Cryoablation is widely used in the management of renal cell carcinoma, with medium-term
outcomes matching surgical resection.
The advantages of cryoablation over surgery, particularly in a paediatric population,
are:
Minimally invasive approach, therefore suitable for day case procedures and almost
scarless
Significantly faster recovery times compared to complex surgical debulking
Minimal complication rates compared to surgery (less risk to nerves, blood vessels
and critical solid organ)
Affords excellent pain relief (has an independent role in chronic pain management)
To date the use of cryoablation in children remains novel and under reported.
The purpose of this registry is to audit the current range of applications, technical
success rate, safety profile, complication rate and efficacy of cryoablation procedures
in children. This registry would, as a minimum, clarify current practice and outcomes
within individual centres, allowing teams to audit and benchmark their own procedures and
aiming to align practice amongst individual hospitals. A registry would aim to generate a
body of evidence to establish parameters for best practice and may highlight conditions
that respond better or worse than others to this novel therapy. The audit may lead to a
clinical trial for the treatment of one or more specific conditions but in the interim
would provide evidence for the efficacy and safety of the procedure and will aim to
protect against indiscriminate use of this treatment modality in children in the future.
Registry design: This is a prospective multi-centre, open, non-controlled repeat
treatment registry and data collection in collaboration with individual hospitals in the
UK and Europe.
The proposal is for a robust, multi-centre data collection system to support and
establish the treatment pathway, safety parameters and outcomes of paediatric
cryoablation. The number of procedures performed in each centre will be understandably
small, given the specialist nature of this emerging modality and the small numbers of
patients being offered this treatment. The registry aims to collect standardised data
from all centres performing cryoablation in children to allow robust audit of this
procedure. Multiple data sets will be collected and entered into an anonymised web based
host.
Upon completion of recruitment and follow up, the data will be subject to uni-variate and
multi-variate analysis.
The registry is designed with the patient at the centre of the data collection and
outcomes. Anonymised data will be analysed collectively but will ultimately be owned and
retained by individual trusts. Details of the full data set proposed are detailed in the
attached study protocol.