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No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Traditional RFA
No-touch RFA
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Small Hepatocellular Carcinoma, No-touch RFA, Traditional RFA, Recurrence rate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of hepatobiliary surgery,Southwest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional RFA

No-touch RFA

Arm Description

Using Traditional RFA for the treatment of small hepatocellular carcinoma

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

Outcomes

Primary Outcome Measures

Recurrence Rate

Secondary Outcome Measures

Recurrence-free Survival Rate
Overall Survival Rate

Full Information

First Posted
July 5, 2016
Last Updated
September 13, 2017
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02830737
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Small Hepatocellular Carcinoma, No-touch RFA, Traditional RFA, Recurrence rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional RFA
Arm Type
Active Comparator
Arm Description
Using Traditional RFA for the treatment of small hepatocellular carcinoma
Arm Title
No-touch RFA
Arm Type
Experimental
Arm Description
Using No-touch RFA for the treatment of small hepatocellular carcinoma
Intervention Type
Procedure
Intervention Name(s)
Traditional RFA
Other Intervention Name(s)
RFA
Intervention Description
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center
Intervention Type
Procedure
Intervention Name(s)
No-touch RFA
Intervention Description
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor)
Primary Outcome Measure Information:
Title
Recurrence Rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Recurrence-free Survival Rate
Time Frame
3 years
Title
Overall Survival Rate
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Kuansheng, Ph.D
Organizational Affiliation
Institute of hepatobiliary surgery,Southwest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of hepatobiliary surgery,Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

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