No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

NCT02830737 | Unknown DMC

• 1 other identifier: SWH2015LC02
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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

Keywords

Small Hepatocellular Carcinoma; No-touch RFA; Traditional RFA; Recurrence rate

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate

  3 years

Secondary Outcomes (2)

• Recurrence-free Survival Rate

  3 years

• Overall Survival Rate

  3 years

Other Outcomes (1)

• Number of Participants with Adverse Events

  3 years

Study Arms (2)

Traditional RFA

ACTIVE COMPARATOR

Using Traditional RFA for the treatment of small hepatocellular carcinoma

Procedure: Traditional RFA

No-touch RFA

EXPERIMENTAL

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

Procedure: No-touch RFA

Interventions

Traditional RFA PROCEDURE

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

Also known as: RFA

Traditional RFA

No-touch RFA PROCEDURE

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

No-touch RFA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• A single tumor with a diameter ≤3cm;
• The tumor that has not invaded the portal vein, the hepatic vein, or the secondary branch;
• Liver function classified as Child A or B;
• 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;
• No significant coagulopathy: platelet count \> 50,000,000,000 /L, prolonged prothrombin time \< 5 seconds;
• Age 18 - 70 years old;
• No acceptance of other anti-cancer therapy before the treatment.

You may not qualify if:

• Complication of severe portal hypertension: a history of upper gastrointestinal bleeding, a history of severe hypersplenism, or refractory ascites;
• Patients with extrahepatic metastasis or lymph node metastasis;
• Patients with multiple liver tumors found from imaging exam or during the treatment;
• Patients with pathological examinations showing the other tissue type of liver cancer after the treatment;
• Patients who expect to receive a liver transplant;
• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Institute of hepatobiliary surgery,Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ma Kuansheng, Ph.D

  Institute of hepatobiliary surgery,Southwest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Candidate of Doctor in Medicine

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 13, 2016
• Study Start: January 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

CN (1)