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Trial Title:
The Efficacy and Safety of EOB-MRI Guided Microwave Ablation for Early HCC: A Multicenter, Prospective, Observational Study
NCT ID:
NCT06096896
Condition:
Early Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
early HCC; microwave ablation; efficacy; safety
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
MWA
Description:
Microwave ablation (MWA) was performed under EOB-MRI guidance in patients with confirmed
or suspected eHCC.
Arm group label:
single-group with MWA
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.
Criteria for eligibility:
Study pop:
Patients with chronic liver disease at high-risk or extremely high-risk of hepatocellular
carcinoma and EOB-MRI shows a confirmed or suspected eHCC.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong PH
Address:
City:
Jinan
Country:
China
Start date:
August 30, 2023
Completion date:
September 30, 2030
Lead sponsor:
Agency:
Shandong Provincial Hospital
Agency class:
Other
Source:
Shandong Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06096896
