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

Microwave Ablation Versus Laparoscopic Hepatectomy for 3-5cm Hepatocellular Carcinoma: a Multicentre Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Cost; Overall Survival; Progression-free Survival
• Intervention / Treatment: Procedure: Microwave Ablation

• Study Type: Interventional
• Enrollment (Actual): 1585
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Microwave Ablation; 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.	Procedure: Microwave Ablation; Microwave Ablation: A minimally invasive technique for HCC, 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. Laparoscopic Hepatectomy: The technique has been widely promoted worldwide with technical progress. In patients with cirrhosis, LLR has the potential advantage of reducing the risk of postoperative liver decompensation; Other Names: Laparoscopic Hepatectomy
Active Comparator: Laparoscopic Hepatectomy; 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.	Procedure: Microwave Ablation; Microwave Ablation: A minimally invasive technique for HCC, 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. Laparoscopic Hepatectomy: The technique has been widely promoted worldwide with technical progress. In patients with cirrhosis, LLR has the potential advantage of reducing the risk of postoperative liver decompensation; Other Names: Laparoscopic Hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death	More than 3 years
Progession-free survival	DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.	More than 3 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 1, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: April 1, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: S2019-348-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with the consent of the corresponding author.
• IPD Sharing Time Frame: Data can be shared with the consent of the corresponding author.
• IPD Sharing Access Criteria: Data can be shared with the consent of the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No