No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Traditional RFA; Procedure: No-touch RFA

• Registration Number: NCT02830737
• Lead Sponsor: Southwest Hospital, China

Brief Summary

Traditional RFA treatment has been a curable therapy for small hepatocellular carcinoma (diameter≤3cm). This technique ablates the tumor via radio frequency by inserting an electrode needle directly into the tumor. This clearly violates no-touch technique based on the principle of surgical oncology. Thus the 1-year recurrence rate of the cancer is up to 30% after the treatment, and the 3-year tumor-free survival rate is only 20% - 40%. No-touch RFA treatment avoids the direct contact with the tumor that can cause the spread of cancer cells in the liver, or the Antrim spread, Therefore it has been suggested that no-touch RFA treatment reduce the recurrence rate after operation in comparison with the traditional RFA treatment. This research project aims at using the prospective randomized comparative method to compare the short-term and the long-term curative effects between no-touch RFA and traditional RFA treatments for small hepatic carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-15
• Primary Completion: 2020-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

1. Primary hepatocellular carcinoma, according to the postoperative pathological examination as the standard, or the diagnostic criteria with reference to the 2012 American Association for the Study of Liver Diseases if the pathological evidence is not available;
2. A single tumor with a diameter ≤3cm;
3. The tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch;
4. Liver function classified as Child A or B;
5. Liver reserve function test with ICG-R15 (indocyanine green retention at 15min) ≤30%, and the important organs that can function with the tolerance of RFA or partial hepatectomy;
6. No significant coagulopathy: platelet count > 50,000,000,000 /L, prolonged prothrombin time < 5 seconds;
7. Age 18 - 70 years old;
8. No acceptance of other anti-cancer therapy before the treatment.

Exclusion Criteria

1. Complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites;
2. Patients with extrahepatic metastasis or lymph node metastasis;
3. Patients with multiple liver tumors found from imaging exam or during the treatment;
4. Patients with pathological examinations showing the other tissue type of liver cancer after the treatment;
5. Patients who expect to receive a liver transplant;
6. Patients whose preoperative imaging exam indicates the tumor close to the gallbladder, hilar major blood vessels, bile ducts and surrounding vital organs, with a potential of serious injury by mistake or serious complications during the treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional RFA	Traditional RFA	Using Traditional RFA for the treatment of small hepatocellular carcinoma
No-touch RFA	No-touch RFA	Using No-touch RFA for the treatment of small hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
Recurrence Rate	3 years

Secondary Outcome Measures

Name	Time	Method
Recurrence-free Survival Rate	3 years
Overall Survival Rate	3 years

Trial Locations

Locations (1)

Institute of hepatobiliary surgery,Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China