Clinical trial NCT06096896: The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study
Official title: The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Early Hepatocellular Carcinoma
Keywords: early HCC; microwave ablation; efficacy; safety
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-24
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease at high-risk or extremely high-risk of hepatocellular carcinoma and EOB-MRI shows a confirmed or suspected eHCC.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 5-years overall survival (OS) after MWA for early HCC
timeFrame: 5 years
Secondary outcomes:
measure: Rate of completed ablation after MWA
timeFrame: rate of completed ablation at one month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong PH
Study officials:
References:
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