To Compare the Efficacy of Microwave Ablation and Laparoscopic Hepatectomy for Hepatocellular Carcinoma

A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm

The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm).

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy

Detailed Description

Research objectives:

To compare the clinical efficacy of percutaneous microwave ablation and laparoscopic resection for hepatocellular carcinoma (tumor diameter 3.1-5.0cm).

Research background:

Liver cancer is the sixth most common tumor in the world and the second leading cause of death. Due to the hepatitis B epidemic, the incidence of liver cancer in China is very high, accounting for about half of the global statistics on the number of new liver cancer cases and deaths each year. Current treatment guidelines recommend surgical resection or transplantation as the gold standard for the treatment of very early or early HCC patients. Meanwhile, local ablation is gradually accepted by clinicians for its minimally invasive nature, safety and efficacy, and it is recommended as an alternative treatment for tumors within 3cm. However, the choice of treatment for 3.1-5cm HCC based on a number of current retrospective studies is controversial. Therefore, we designed this study to provide reliable prospective data to support the selection of therapeutic modalities for HCC.

Technical introduction:

Microwave ablation (MWA) is an ultrasound guided ablation electrode implanted in the target tissue, in the form of electromagnetic waves to generate microwave energy, microwave can make the surrounding tissue in the water molecules oscillate against the friction of heat, high temperature heat causes rapid coagulation necrosis of the tissue, so as to achieve the purpose of local tumor treatment. Compared with other ablation techniques, MWA in the treatment of solid tumors can achieve higher tumor internal temperature in a shorter period of time, with strong penetration, synergistic effect of multi-needle combined ablation, and little influence by carbonization and blood perfusion. Therefore, MWA has fast heat production, high intracellular temperature, short ablation time and large ablation range.

Laparoscopic liver resection (Laparoscopic hepatectomy) reported for the first time in 1991 by the professor Reich. Laparoscopic techniques in the application in benign (malignant) liver disease is widespread. In China, since professor Weiping Zhou and others completed the first laparoscopic liver resection in mainland China in 1994, there have been continuous literature reports, and the scope and difficulty of surgical resection have been increasing.The 2008 Louisville declaration states that laparoscopic liver surgery is safe and effective for surgeons with extensive experience in hepatobiliary surgery and laparoscopic surgery.

Research methods In this study, 1134 patients were expected to be enrolled according to the 1:1 grouping of the experimental group and the control group. The efficacy of the two treatment methods was evaluated by comparing the overall survival of the two groups and other indicators.

• Study Type: Interventional
• Enrollment (Anticipated): 1134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous microwave ablation group; MWA (Microwave) is an ultrasound-guided, minimally invasive technique that implants ablation electrodes into target tissue to rapidly generate high temperatures and rapidly develop coagulative necrosis in tumor tissue, thereby achieving the goal of local tumor treatment.	Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy; For patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology.
Other: Laparoscopic hepatectomy; Laparoscopic hepatectomy is a widely used surgical technique in the treatment of benign (malignant) liver diseases	Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy; For patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death).	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Defined as the period of time between the time the patient is treated and the time the disease progresses or death from any cause is observed	60 months
Intrahepatic recurrence rate	Defined as the proportion of patients with intrahepatic recurrence from the beginning of the study to the end of the study or the death of the patients	60 months
Rate of extrahepatic metastasis	Defined as the proportion of cases with extrahepatic metastasis from the beginning of the study to the end of the study or the death of the patient	60 months
Local rate of progression	Defined as the proportion of patients with active tumor at the edge of the treatment area during follow-up after the tumor was completely treated	60 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: microwave ablation, hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 2019002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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