Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma

Chinese PLA General Hospital (301 Hospital)

Status: Completed

Conditions: Overall Survival; Progression-free Survival; Cost

Treatments: Procedure: Microwave Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05796700

S2019-348-01

Details and patient eligibility

About

As the most common subtype of liver cancer (85% ~ 90%), HCC is highly malignant; thus, one of the crucial issues in HCC management is an effective therapy for tumors at an early stage, which is vital for improving the prognosis of patients. For ≤3cm HCC, ablation has been recommended by international guidelines as a first-line or alternative treatment because of similar survival outcomes and milder liver function injury with liver resection (LR). However, the appropriate treatment options for 3-5cm HCC remain controversial. Thus, none of the international guidelines recommend ablation as a first-line treatment for 3-5cm HCC. In the past few decades, treatment for HCC has tended to be less invasive, have fewer complications, and have higher cost-effectiveness. Compared with LR, laparoscopic Hepatectomy (LH) demonstrates the advancement of minimal invasion. As another minimally invasive technique for HCC, Microwave Ablation (MWA) has the potential to eradicate larger HCCs with larger coagulation areas and is less affected by the heat sink effect caused by vessels around the tumor. Many studies have identified the potential advantages of MWA over other ablation techniques. However, to date, no clinical studies have compared the efficacy of LH and MWA therapies for 3-5cm HCC with periodic progression.

Enrollment: 1,585 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

i) age ≥18 years ii) all patients with an initial diagnosis of 3-5cm HCC(within 3 tumors, at least one 3-5cm) by histopathology iii) Child-Pugh class A or B iv) no vascular invasion or distant metastasis v) no other malignant neoplasms within the last 5 years

Exclusion criteria

i) age <18 years ii) Child-Pugh class ≥B iii) vascular invasion or distant metastasis iv) with other malignant neoplasms within the last 5 years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,585 participants in 2 patient groups

Microwave Ablation

Active Comparator group

Description:

According to the shape, size and location of each patient's tumor, as well as the adjacent relationship with the surrounding organs, the individual MWA scheme was pre-established. Contrast-enhanced CT (CE-CT) or contrast-enhanced magnetic resonance imaging (CE-MRI) was used to evaluate complete ablation within 3 to 5 days after ablation. If radiography suggested incomplete ablation, supplementary ablation was performed as soon as the patient's condition permitted. A cooled-shaft MW system (KY-2000, Kangyou Medical, China) was used in the procedure.

Treatment:

Procedure: Microwave Ablation

Laparoscopic Hepatectomy

Active Comparator group

Description:

The optimal surgical procedure for each patient depends on the characteristics of the tumor. Patients were placed in French position and a laparoscopic-assisted partial hepatectomy was performed under CO2 pneumoperitoneum pressure 12-14 mmHg (1 mmHg =0.133 kPa). In most cases, a 4-well or 5-well method was used under general anesthesia.

Treatment:

Procedure: Microwave Ablation