Comparing microwave ablation and laparoscopic surgery for liver cancer
A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm
This study is testing whether microwave ablation or laparoscopic surgery works better for treating liver cancer tumors that are between 3.1 and 5.0 cm in size.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04365751 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of percutaneous microwave ablation and laparoscopic resection in treating hepatocellular carcinoma (HCC) tumors measuring 3.1-5.0 cm. It is a prospective multicenter cohort control study that divides participants into two groups to evaluate clinical outcomes. The research is motivated by the high incidence of liver cancer in China and the need for reliable data to guide treatment decisions for patients with early-stage HCC. The study will provide insights into the safety and efficacy of these two treatment modalities.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a confirmed diagnosis of hepatocellular carcinoma and tumors between 3.1-5.0 cm in size.
Not a fit: Patients with severe liver conditions, such as hepatic decompensation or significant complications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective treatment option for patients with early-stage liver cancer, potentially improving patient outcomes.
How similar studies have performed: While there is ongoing debate regarding treatment options for HCC of this size, previous studies have shown promising results for both microwave ablation and laparoscopic resection, indicating potential for success in this comparative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Older than 18 years old, regardless of gender; 2.In patients without cirrhosis background, hepatocellular carcinoma was definitely pathologically diagnosed within 1 month before surgery. In patients with cirrhosis background, dynamic contrast enhanced MRI/ multi-stage dynamic enhanced CT were used to determine the characteristic vascular signs of primary liver cancer (rapid heterogeneous vascular enhancement in arterial phase, rapid elution in venous phase or delayed phase); 3.The number of tumors was ≤3, and the maximum diameter of at least one tumor was 3.1-5.0cm; 4.No vascular and lymph node invasion and distant metastasis; 5.Liver function: child-pugh A or B (assessed within 14 days before surgery); 6.Subjects will understand the purpose of the study, voluntarily participate and sign the informed consent. Exclusion Criteria: * 1.Severe hepatic decompensation, presence of hepatic encephalopathy, massive ascites or gastrointestinal bleeding within 1 month; 2.Clotting disorders or bleeding tendencies (platelet count \<50 x 109 / L or INR\>1.5); 3.Patients with severe cardiac, pulmonary and renal insufficiency; 4.Combined with active infection; 5.Pregnant patients; 6.A history of drug abuse and mental illness; 7.Inability to tolerate pneumoperitoneum; 8.Other studies or anti-tumor therapists in the first four weeks of the study; 9.The researchers determined that there were any other factors that were inappropriate for inclusion or that affected participants' participation in the study.
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Ping Liang, Doctor — Chinese PLA General Hospital
- Study coordinator: Jie Yu, Doctor
- Email: jiemi301@163.com
- Phone: 8601066939530
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.