No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

NCT ID: NCT02830737

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional RFA

Using Traditional RFA for the treatment of small hepatocellular carcinoma

Group Type: ACTIVE_COMPARATOR

Traditional RFA

Intervention Type: PROCEDURE

Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center

No-touch RFA

Using No-touch RFA for the treatment of small hepatocellular carcinoma

Group Type: EXPERIMENTAL

No-touch RFA

Intervention Type: PROCEDURE

Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor)

Interventions

Traditional RFA

Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

Other Intervention Names

RFA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southwest Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Yuelong Chai

Candidate of Doctor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ma Kuansheng, Ph.D

Role: STUDY_DIRECTOR

Institute of hepatobiliary surgery,Southwest Hospital

Locations

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

SWH2015LC02

Identifier Type: -

Identifier Source: org_study_id