Cargando…

Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study

PURPOSE: To assess the feasibility and safety of a robotic system for percutaneous needle insertion during thermal ablation of liver tumors. MATERIALS AND METHODS: This study analyzed the CT-guided percutaneous needle insertion using the EPIONE robotic device (Quantum Surgical, Montpellier, France)...

Descripción completa

Detalles Bibliográficos
Autores principales: de Baère, Thierry, Roux, Charles, Deschamps, Frédéric, Tselikas, Lambros, Guiu, Boris
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9626422/
https://www.ncbi.nlm.nih.gov/pubmed/36127519
http://dx.doi.org/10.1007/s00270-022-03267-z
_version_ 1784822728025440256
author de Baère, Thierry
Roux, Charles
Deschamps, Frédéric
Tselikas, Lambros
Guiu, Boris
author_facet de Baère, Thierry
Roux, Charles
Deschamps, Frédéric
Tselikas, Lambros
Guiu, Boris
author_sort de Baère, Thierry
collection PubMed
description PURPOSE: To assess the feasibility and safety of a robotic system for percutaneous needle insertion during thermal ablation of liver tumors. MATERIALS AND METHODS: This study analyzed the CT-guided percutaneous needle insertion using the EPIONE robotic device (Quantum Surgical, Montpellier, France) for radiofrequency or microwave liver ablation. The main criteria of the study were feasibility (possibility to perform the thermal ablation after needle insertion), the number of needle adjustments (reiteration of robotically assisted needle insertion when initial needle positioning is considered insufficient to perform ablation), and robotic-guided procedure safety (complications related to the needle insertion). Patients were followed up at 6 months post-intervention to assess local tumor control. RESULTS: Twenty-one patients with 24 tumors, including 6 HCC and 18 metastases measuring 15.6 ± 7.2 mm, were enrolled. One patient (with one tumor) was excluded for protocol deviation. Robotic assisted thermal ablation was feasible for 22/23 lesions (95.7%) and 19/20 patients (95.0%), as validated by a data safety monitoring Board (95% CI [76.39%; 99.11%]) for the per-protocol population. The mean number of needle adjustments per tumor treated was 0.4 (SD: 0.7), with 70.8% of tumors requiring no adjustment. No adverse events were depicted. Rate of local tumor control was 83.3% for patients and 85.7% for tumors, at 6 months. CONCLUSION: This bicentric first-in-human pilot study suggests both feasibility and safety of a stereotactic CT-guided EPIONE device for the percutaneous needle insertion during liver tumor thermal ablation.
format Online
Article
Text
id pubmed-9626422
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer US
record_format MEDLINE/PubMed
spelling pubmed-96264222022-11-03 Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study de Baère, Thierry Roux, Charles Deschamps, Frédéric Tselikas, Lambros Guiu, Boris Cardiovasc Intervent Radiol Clinical Investigation PURPOSE: To assess the feasibility and safety of a robotic system for percutaneous needle insertion during thermal ablation of liver tumors. MATERIALS AND METHODS: This study analyzed the CT-guided percutaneous needle insertion using the EPIONE robotic device (Quantum Surgical, Montpellier, France) for radiofrequency or microwave liver ablation. The main criteria of the study were feasibility (possibility to perform the thermal ablation after needle insertion), the number of needle adjustments (reiteration of robotically assisted needle insertion when initial needle positioning is considered insufficient to perform ablation), and robotic-guided procedure safety (complications related to the needle insertion). Patients were followed up at 6 months post-intervention to assess local tumor control. RESULTS: Twenty-one patients with 24 tumors, including 6 HCC and 18 metastases measuring 15.6 ± 7.2 mm, were enrolled. One patient (with one tumor) was excluded for protocol deviation. Robotic assisted thermal ablation was feasible for 22/23 lesions (95.7%) and 19/20 patients (95.0%), as validated by a data safety monitoring Board (95% CI [76.39%; 99.11%]) for the per-protocol population. The mean number of needle adjustments per tumor treated was 0.4 (SD: 0.7), with 70.8% of tumors requiring no adjustment. No adverse events were depicted. Rate of local tumor control was 83.3% for patients and 85.7% for tumors, at 6 months. CONCLUSION: This bicentric first-in-human pilot study suggests both feasibility and safety of a stereotactic CT-guided EPIONE device for the percutaneous needle insertion during liver tumor thermal ablation. Springer US 2022-09-20 2022 /pmc/articles/PMC9626422/ /pubmed/36127519 http://dx.doi.org/10.1007/s00270-022-03267-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Clinical Investigation
de Baère, Thierry
Roux, Charles
Deschamps, Frédéric
Tselikas, Lambros
Guiu, Boris
Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title_full Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title_fullStr Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title_full_unstemmed Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title_short Evaluation of a New CT-Guided Robotic System for Percutaneous Needle Insertion for Thermal Ablation of Liver Tumors: A Prospective Pilot Study
title_sort evaluation of a new ct-guided robotic system for percutaneous needle insertion for thermal ablation of liver tumors: a prospective pilot study
topic Clinical Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9626422/
https://www.ncbi.nlm.nih.gov/pubmed/36127519
http://dx.doi.org/10.1007/s00270-022-03267-z
work_keys_str_mv AT debaerethierry evaluationofanewctguidedroboticsystemforpercutaneousneedleinsertionforthermalablationoflivertumorsaprospectivepilotstudy
AT rouxcharles evaluationofanewctguidedroboticsystemforpercutaneousneedleinsertionforthermalablationoflivertumorsaprospectivepilotstudy
AT deschampsfrederic evaluationofanewctguidedroboticsystemforpercutaneousneedleinsertionforthermalablationoflivertumorsaprospectivepilotstudy
AT tselikaslambros evaluationofanewctguidedroboticsystemforpercutaneousneedleinsertionforthermalablationoflivertumorsaprospectivepilotstudy
AT guiuboris evaluationofanewctguidedroboticsystemforpercutaneousneedleinsertionforthermalablationoflivertumorsaprospectivepilotstudy