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

NCT06450613 | Completed

• 1 other identifier: 68277917.4.0000.0071
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cost Effectiveness; Exposure to Radiofrequency

Outcome Measures

Primary Outcomes (1)

• RFA versus PEI imaging response rate

  To compare the objective response rate in magnetic resonance imaging performed approximately 60 days after radiofrequency ablation treatment or percutaneous alcohol injection as neoadjuvant therapy in patients with early-stage hepatocellular carcinomas (BCLC-A) on the waiting list for liver transplantation, according to mRECIST criteria.

  60 days

Secondary Outcomes (3)

• RFA versus PEI complication rate

  180 days

• Compare the costs between RFA versus PEI

  180 days

• late recurrenceof RFA versus PEI

  180 days

Study Arms (2)

percutaneous ethanol injection

OTHER

early-stage hepatocellular carcinoma within the Milan criteria, listed for LT and with indication for neoadjuvant treatment were eligible for enrollment submitted to percutaneous ethanol injection

Other: percutaneous ethanol injection

Radiofrequency ablation

OTHER

early-stage hepatocellular carcinoma within the Milan criteria, listed for LT and with indication for neoadjuvant treatment were eligible for enrollment submitted to Radiofrequency ablation

Device: radiofrequency ablation

Interventions

radiofrequency ablation DEVICE

HCC Radiofrequency ablation

Radiofrequency ablation

percutaneous ethanol injection OTHER

HCC percutaneous ethanol injection

percutaneous ethanol injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of single or multiple HCC (up to three nodules), measuring between 2.0 and 3.0 cm according to the Barcelona Clinic Liver Cancer (tumor stage A) and Milan criteria.
• LI-RADS 4 or 5 nodule(s) evidenced on MRI for a maximum of 30 days, naïve to local treatment.
• Child-Pugh A and B patients on the liver transplant waiting list.

You may not qualify if:

• Presence of vascular invasion or extrahepatic dissemination;
• Refractory or intractable ascites;
• grade III/IV hepatic encephalopathy;
• Complete thrombosis of the main trunk of the portal vein;
• Total bilirubin \>3mg/dlL;
• Coagulation disorder: INR\>2 and/or platelets\<20,000;
• Performance score (PST) according to the criteria of the Eastern Cooperative Oncology Group (ECOG) ECOG \>2;
• Moderate or severe hydrothorax;
• Renal failure with creatinine clearance\<30 mL/min/1.73 m²mlL/hr;
• Calculated MELD\>30;
• Technical impediments to carrying out PEI or RFA procedures;
• Refusal to sign the Free and Informed Consent Term (TCLE);
• Patients who presented a greater risk with PEI or RFA procedures than the potential benefits of the study.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652900, Brazil

Location

Related Publications (1)

• Mariotti GC, Felga GEG, Garcia RG, Falsarella PM, Schmid BP, Malheiros DT, Baroni RH, Serpa Neto A. Cost-effectiveness of radiofrequency ablation versus percutaneous ethanol injection for early hepatocellular carcinoma in a resource-poor setting: a randomized trial. Einstein (Sao Paulo). 2024 Sep 30;22:eGS0683. doi: 10.31744/einstein_journal/2024GS0683. eCollection 2024.

  PMID: 39356946 DERIVED

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Guilherme Mariotti

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: June 10, 2024
• Study Start: January 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: March 31, 2021
• Last Updated: June 10, 2024

Record last verified: 2021-03

Locations

BR (1)