The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study

N/AActive Not RecruitingNCT06096896

Shandong Provincial Hospital334 enrolled

Overview

HCC is one of most common causes of cancer-related death in the world due to lately diagnosis by typical hallmarks which rely on completed arterialization. So it is important to earlier diagnose and treat hypovascular early HCC(eHCC). The aim of this study is to evaluate the efficacy and safety of microwave ablation for early HCC, also to explore the feasibility of EOB-MRI (Gd-EOB-DTPA enhanced MRI) guided ablation.

Study Type

OBSERVATIONAL

Enrollment

334

Conditions

Early Hepatocellular Carcinoma

Interventions

MWAPROCEDURE

Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed or suspected eHCC.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years; 2. Patients with chronic liver disease who are at high/extremely high-risk of hepatocellular carcinoma; 3. EOB-MRI suggestive of confirmed or suspected eHCC (single lesion ≤ 2 cm or number of lesions ≤ 3 and maximum diameter ≤ 2 cm) 4. No previous history of hepatocellular carcinoma; 5. Not receiving any anti-cancer treatment; 6. Liver function Child-push A or B. Exclusion Criteria: 1. Presence of lymph nodes or distant metastases; 2. Presence of liver metastases; 3. Prior malignancy; 4. Severe cardiopulmonary or renal dysfunction; 5. Suffering from uncorrectable coagulation dysfunction (prothrombin time \> 25 seconds, prothrombin activity \< 40%, platelet count ≤ 50x10\^9/L); 6. Severe infectious lesions in the area of the puncture needle tract.

Locations (1)

Shandong PH

Jinan, China

Outcomes

Primary Outcomes

5-years overall survival (OS) after MWA for early HCC

Analyze the efficacy and safety of EOB-MRI-guided microwave ablation in the treatment of eHCC;

Time frame: 5 years

Secondary Outcomes

Rate of completed ablation after MWA

Ablation effect assessed by EOB-MRI one month after ablation

Time frame: rate of completed ablation at one month

Data from ClinicalTrials.gov

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