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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Early Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: MWA


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single-group with MWA<br>334 patients with confirmed or suspected eHCC as indicated by EOB-MRI were to be included in this study in a population with high or extremely high-risk of hepatocellular carcinoma in chronic liver disease. Then Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed or suspected eHCC. | Procedure: MWA<br>* Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed or suspected eHCC.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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; | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of completed ablation after MWA | Ablation effect assessed by EOB-MRI one month after ablation | rate of completed ablation at one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early HCC; microwave ablation; efficacy; safety