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

Overall Survival Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796700
• Other study ID #: S2019-348-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2008
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1585
• Est. completion date: December 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cost
• Overall Survival
• Progression-free Survival

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Progession-free survival	DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.	More than 3 years