1. Local Tumour Control Following Microwave Ablation: Protocol for the Prospective Observational CIEMAR Study.
- Author
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Pereira PL, Bale R, Fretland ÅA, Goldberg SN, Helmberger T, Meijerink MR, Orsi F, Stättner S, Vogl T, Kafkoula A, de Jong N, Zeka B, and de Baère T
- Subjects
- Adult, Humans, Microwaves therapeutic use, Observational Studies as Topic, Prospective Studies, Quality of Life, Treatment Outcome, Catheter Ablation methods, Colorectal Neoplasms pathology, Liver Neoplasms surgery
- Abstract
Purpose: Microwave ablation (MWA) is a treatment modality for colorectal liver metastases (CRLM). While potentially curative, more information is needed on factors that contribute to long-term local tumour control. The prospective multicentre observational study CIRSE Emprint Microwave Ablation Registry aims to prospectively collect real-world technical data and clinical outcomes on patients treated with MWA in CRLM., Methods: Eligible patients are adults with up to 9 local treatment naïve CRLM of ≤ 3 cm completely treatable with either MWA alone or MWA with resection and/or radiotherapy within 8 weeks. Data are collected, at baseline, every 3 months until 12 months, and thereafter every 6 months until the end of the study. The primary outcome measure is local tumour control. Secondary outcome measures are overall survival, (hepatic-) disease-free survival, time-to-progression untreatable by ablation, systemic therapy vacation, safety, and quality of life. Covariates related to the primary outcome measure will be assessed using a stratified log-rank test and an univariable Cox proportional hazard regression. A sample size of 500 patients with 750 lesions produces a two-sided 95% confidence interval with a precision equal to 0.057., Results: Between September 2019 and December 2022, 500 patients have been enrolled with at least 976 treated tumours., Conclusion: The prospective observational CIEMAR study will provide valuable insights into the real-world use of MWA, helping in the future patient selection and clarifying factors that may contribute to long-term local tumour control., Trial Registration: NCT03775980., (© 2023. The Author(s).)
- Published
- 2024
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