No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02830737
• Other study ID #: SWH2015LC02
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 5, 2016
• Last updated: September 13, 2017
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: September 2017
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 178
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Traditional RFA
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center
• No-touch RFA
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor)

Locations

Country	Name	City	State
China	Institute of hepatobiliary surgery,Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events		3 years
Primary	Recurrence Rate		3 years
Secondary	Recurrence-free Survival Rate		3 years
Secondary	Overall Survival Rate		3 years