Infant and Child European Cryoablation Project ICECaP

Occurrence and severity of complications arising from cryoablation treatment

Documentation and severity scoring of any complications arising from a cryoablation procedure, using the Society of Interventional Radiology (SIR) standards of practice committee classification of complications by outcome scoring system. The range of the outcome scoring system is A-F, with A being the least severe (no therapy, no consequence), and F being the most severe (resulting death). \[Omary et al. J Vasc Interv Radiol 2003; 14:S293-S295\]

Change in maximal diameter of lesion following treatment

In patients where this is applicable, measure change in maximal lesion diameter on ultrasound or MRI imaging, comparing baseline (pre-treatment) lesion diameter to (post treatment) lesion diameter at 2 years. Subsequent lesion measurements will be made annually up to 5 years (for patients included in follow up).

Change in symptomatology following treatment

Where applicable, measure change in symptomatology post treatment, as assessed by PedsQL Pediatric Quality of Life Inventory UK questionnaire version 4.0. This is a scored questionnaire used for the assessment of physical functioning, emotional functioning, social functioning and school functioning. It is completed by both the child (child report) and the parent (parent report). Each questionnaire consists of 23 items graded 0-4 where 0 equates to no functional deficit and a maximum achievable score of 92 equates to the most severe functional deficit. Combined parent and child reports are collated to give a range of scores of 0-184 per assessment.

Procedure failure

This is a composite outcome defined as having the presence of any (or all) of the following: absence of consent, patient not fit for procedure, clinical complication, technical failure of equipment. This data will be collected over the 3 years of procedure recruitment into the registry.