Clinical trial NCT02830737: No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma
Official title: Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Small Hepatocellular Carcinoma
No-touch RFA
Traditional RFA
Recurrence rate
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recurrence Rate
timeFrame: 3 years
Secondary outcomes:
measure: Recurrence-free Survival Rate
timeFrame: 3 years
measure: Overall Survival Rate
timeFrame: 3 years
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 3 years
Locations:
city: Chongqing
country: China
facility: Institute of hepatobiliary surgery,Southwest Hospital
state: Chongqing
Study officials:
affiliation: Institute of hepatobiliary surgery,Southwest Hospital
name: Ma Kuansheng, Ph.D
role: STUDY_DIRECTOR
References: