Comparison of two microwave ablation techniques for liver cancer
A Single-center, Prospective Randomized Controlled Study of Microwave Spherical Ablation and Traditional Microwave Ablation in the Treatment of Single Hepatocellular Carcinoma With a Diameter of ≤5cm
This study is testing whether a new microwave treatment for small liver tumors works better and causes fewer problems than the traditional method for patients with liver cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Third Central Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05361538 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of Microwave Spherical Ablation (MSA) and traditional Microwave Ablation (MWA) in treating single hepatocellular carcinoma tumors that are 5 cm or smaller. The focus is on evaluating progression-free survival, overall survival, local progression rates, complete ablation rates, and complication rates between the two techniques. MSA aims to provide more precise ablation with less damage to surrounding healthy liver tissue, particularly beneficial for patients with liver cirrhosis. The study involves patients who have been diagnosed with hepatocellular carcinoma and are opting for microwave ablation instead of surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a single hepatocellular carcinoma lesion ≤5cm and Child Pugh A or B liver function who refuse surgery.
Not a fit: Patients with prior treatment for the lesion, portal vein invasion, extrahepatic metastases, severe cardiopulmonary insufficiency, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced complications for patients with early-stage liver cancer.
How similar studies have performed: While traditional microwave ablation has been widely used, the novel approach of Microwave Spherical Ablation is still being evaluated for its effectiveness compared to established methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ; 2. Age range 18 to 75 years old; 3. Single lesion with tumor diameter ≤5cm; 4. Patient refuses surgery and determines to undergo microwave ablation 5. Liver function Child Pugh A or B; 6. No extrahepatic metastasis or portal invasion; 7. Patient signs the informed consent. Exclusion Criteria: 1. The lesion has received treatment, including local ablation therapy and TACE therapy, etc; 2. With portal vein invasion or extrahepatic metastases; 3. Patient is with severe cardiopulmonary insufficiency. 4. Patient is a pregnant or breastfeeding women. 5. Patient is considered to be unsuitable to participate in the study
Where this trial is running
Tianjin, Tianjin
- Tianjin Third Central Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Xiang Jing, MD
- Email: dr.jingxiang@aliyun.com
- Phone: 02284112323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.