Clinical trial NCT04365751: To Compare the Efficacy of Microwave Ablation and Laparoscopic Hepatectomy for Hepatocellular Carcinoma
Official title: A Prospective Multicenter Cohort Control Study of Percutaneous Microwave Ablation and Laparoscopic Resection for Hepatocellular Carcinoma With a Diameter of 3.1 ~ 5.0cm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: microwave ablation, hepatocellular carcinoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 1134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

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.

Eligibility criteria: 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 \&lt;50 x 109 / L or INR\&gt;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.

Primary outcomes:
measure: Overall survival
timeFrame: 60 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 60 months
measure: Intrahepatic recurrence rate
timeFrame: 60 months
measure: Rate of extrahepatic metastasis
timeFrame: 60 months
measure: Local rate of progression
timeFrame: 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: