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

NCT05796700 | Completed

• 1 other identifier: S2019-348-01
• Study Type: interventional
• Target: 1,585
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Overall Survival; Progression-free Survival; Cost

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Microwave Ablation

ACTIVE COMPARATOR

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

Laparoscopic Hepatectomy

ACTIVE COMPARATOR

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

Interventions

Microwave Ablation PROCEDURE

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

Also known as: Laparoscopic Hepatectomy

Laparoscopic Hepatectomy; Microwave Ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Related Publications (1)

• Wang Z, Zhang H, Meng Q, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Liu C, Yu XL, Cheng ZG, Liu FY, Han ZY, Dou JP, Yu J, Liang P. A multicenter case-controlled study on laparoscopic hepatectomy versus microwave ablation as first-line therapy for 3-5 cm hepatocellular carcinoma in patients aged 60 and older. Int J Surg. 2024 Mar 1;110(3):1356-1366. doi: 10.1097/JS9.0000000000000839.

  PMID: 38320101 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 3, 2023
• Study Start: January 1, 2008
• Primary Completion: October 31, 2019
• Study Completion: December 30, 2020
• Last Updated: April 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data can be shared with the consent of the corresponding author.
• Access Criteria: Data can be shared with the consent of the corresponding author.