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Exposure to Radiofrequency clinical trials

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NCT ID: NCT06450613 Completed - Cost Effectiveness Clinical Trials

Cost-effectiveness of RFA vs. PEI for Early-stage HCC

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Introduction: Liver transplantation(LT) is the gold-standard treatment for unresectable early-stage HCC within the Milan criteria. However, long waiting time can lead to dropout from LT candidacy. Local ablative procedures play a key role in the patient care enabling downsizing. Radiofrequency ablation(RFA) and percutaneous ethanol injection(PEI) are two valuable non-surgical neoadjuvant alternatives, but the most cost-effective treatment strategy remains controversial. Purpose: to assess whether RFA is cost-effective compared to PEI in adult patients with early-stage hepatocellular carcinoma within the Milan criteria. Methods: a pilot, single-center, randomized, open-label trial, with blinded end-point assessment, in which PEI was compared with RFA. Patients with early-stage hepatocellular carcinoma within the Milan criteria, listed for LT and indication for neoadjuvant treatment were eligible for enrollment. The primary outcome was the complete response rate according to mRECIST criteria at 60 days after the treatment. Secondary outcomes were the costs, rates and degrees of complications and the cost-effectiveness analysis of both techniques.