Original Title: Sistemas de navegación virtual estereotáctica para ablación tumoral percutánea

Authors' objectives: The report will answer the research question on the safety and clinical efficacy/effectiveness of radiofrequency or microwave thermoablation via percutaneous puncture guided by stereotactic virtual navigation systems with malign hepatic/renal/pulmonary tumours, compared to thermoablation via percutaneous puncture guided by conventional imaging techniques.

Authors' results and conclusions: Ten articles were selected from the 3895 references identified. Eight of the selected studies answered the effectiveness and safety questions, seven related to liver tumours and one to lung tumours. The other 2 selected studies, related to the liver, only respond to the safety variable, as they did not present a comparison group. No studies were found describing the effectiveness or safety of the technology in the management of renal tumours. Only 71% (4/7) of the liver tumour studies presented results on the variable success rate (probability of complete removal of tumour tissue assessed by contrast-enhanced CT or MRI after ablation). The analysis on this variable shows that the probability of success with SVNS is slightly higher than the intervention without SVNS, but is not statistically significant (RR =1.05; 95%CI: 0.97-1.14). The variables accuracy and number of readjustments were included in 42% (3/7) of the studies. As it was measured differently, it was not possible to calculate a joint estimator for the accuracy variable. As for the variable number of readjustments, there were no differences between the approach with or without SVNS. The study on lung tumours only reported results on the variable of readjustments, showing no differences between the groups. In terms of safety, the intervention with SVNS is less likely to have serious adverse effects; however, for mild/moderate adverse effects, the intervention without SVNS is less likely to have serious adverse effects. No economic studies on SVNS were retrieved. Regarding the impact on the organisation of the implementation of the SVNS intervention, only three studies compare the total intervention time with SVNS versus not using SVNS. In only one of the three studies is the difference in time significant, being lower in the SVNS group. None of the included studies reported data on the learning curve required to manage the systems. Conclusions: Studies on the effectiveness of VNS-guided thermoablation have only been found for liver tumours. These studies are of low quality and at high risk of bias, so the results should be interpreted with caution. The evidence reviewed suggests that there is no difference in effectiveness compared to not using these systems and that the safety of virtual navigation systems is similar to that obtained in thermal ablations performed without virtual navigation systems, although they could improve the radiation dose per procedure received by patients. The use of virtual navigation systems has an impact on the healthcare system as it requires an investment both for the purchase, rental of the equipment, or transfer due to the cost of consumables; as well as the cost of the learning curve for professionals. The virtual navigation system could be an option for patients with indications or thermoablation and with lesions that are not visible on ultrasound or difficult to locate by other imaging techniques, but studies would be needed to evaluate the results in these patients.

Authors' recommendations: Ten articles were selected from the 3895 references identified. Eight of the selected studies answered the effectiveness and safety questions, seven related to liver tumours and one to lung tumours. The other 2 selected studies, related to the liver, only respond to the safety variable, as they did not present a comparison group. No studies were found describing the effectiveness or safety of the technology in the management of renal tumours. Only 71% (4/7) of the liver tumour studies presented results on the variable success rate (probability of complete removal of tumour tissue assessed by contrast-enhanced CT or MRI after ablation). The analysis on this variable shows that the probability of success with SVNS is slightly higher than the intervention without SVNS, but is not statistically significant (RR =1.05; 95%CI: 0.97-1.14). The variables accuracy and number of readjustments were included in 42% (3/7) of the studies. As it was measured differently, it was not possible to calculate a joint estimator for the accuracy variable. As for the variable number of readjustments, there were no differences between the approach with or without SVNS. The study on lung tumours only reported results on the variable of readjustments, showing no differences between the groups. In terms of safety, the intervention with SVNS is less likely to have serious adverse effects; however, for mild/moderate adverse effects, the intervention without SVNS is less likely to have serious adverse effects. No economic studies on SVNS were retrieved. Regarding the impact on the organisation of the implementation of the SVNS intervention, only three studies compare the total intervention time with SVNS versus not using SVNS. In only one of the three studies is the difference in time significant, being lower in the SVNS group. None of the included studies reported data on the learning curve required to manage the systems. Conclusions: Studies on the effectiveness of VNS-guided thermoablation have only been found for liver tumours. These studies are of low quality and at high risk of bias, so the results should be interpreted with caution. The evidence reviewed suggests that there is no difference in effectiveness compared to not using these systems and that the safety of virtual navigation systems is similar to that obtained in thermal ablations performed without virtual navigation systems, although they could improve the radiation dose per procedure received by patients. The use of virtual navigation systems has an impact on the healthcare system as it requires an investment both for the purchase, rental of the equipment, or transfer due to the cost of consumables; as well as the cost of the learning curve for professionals. The virtual navigation system could be an option for patients with indications or thermoablation and with lesions that are not visible on ultrasound or difficult to locate by other imaging techniques, but studies would be needed to evaluate the results in these patients.

Authors' methods: A systematic review was carried out of the scientific evidence published from January 2011 to January 2022 in databases specialised in Systematic Reviews and Health Technology Assessment Reports and in general databases (Medline and Embase). The question to be answered was formulated following the PICOD format: i) Population: adults over 18 years of age with a diagnosis of hepatic/ renal/pulmonary tumours; ii) the intervention was defined as radiofrequency or microwave thermoablation via CT-guided percutaneous puncture assisted by an SVNS.; iii) the comparator was defined as hermoablation via percutaneous puncture guided by conventional imaging techniques without SVNS; iv) The outcome variables studied were: success rate of the intervention, short- and long-term survival, short- and long-term quality of life and length of hospital stay for efficacy/effectiveness. For safety we included: rate of adverse events during the intervention such as haemorrhage, pneumothorax, infection or death and level of radiation; v) Systematic reviews, meta-analyses and clinical practice guidelines and primary comparative studies (randomised and controlled clinical trials, quasi-experimental studies, cohort studies and case-control studies) were included.

Project Status: Completed

URL for project: https://acis.sergas.gal/cartafol/NavegacionEstereotacticaTpercutaneos

Year Published: 2023

URL for published report: http://hdl.handle.net/20.500.11940/17562

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: <p>Galician Agency for Health Technology Assessment (AVALIA-T)</p>