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No-touch RFA Versus Traditional RFA for Small Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT02830737
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Yuelong Chai, Southwest Hospital, China

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Traditional RFA Procedure: No-touch RFA Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Comparative Study on No-touch Radiofrequency Ablation Treatment of Small Hepatocellular Carcinoma
Study Start Date : January 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Traditional RFA
Using Traditional RFA for the treatment of small hepatocellular carcinoma
Procedure: Traditional RFA
Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center
Other Name: RFA

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




Primary Outcome Measures :
  1. Recurrence Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Recurrence-free Survival Rate [ Time Frame: 3 years ]
  2. Overall Survival Rate [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Number of Participants with Adverse Events [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830737


Locations
China, Chongqing
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Study Director: Ma Kuansheng, Ph.D Institute of hepatobiliary surgery,Southwest Hospital

Responsible Party: Yuelong Chai, Candidate of Doctor in Medicine, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02830737     History of Changes
Other Study ID Numbers: SWH2015LC02
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yuelong Chai, Southwest Hospital, China:
Small Hepatocellular Carcinoma
No-touch RFA
Traditional RFA
Recurrence rate

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases