The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.

August 11, 2020 updated by: fengkai, Southwest Hospital, China

The Short-term Efficacy of Novel No-touch Combined Directional Perfusion Radiofrequency Ablation in the Treatment of Small Hepatocellular Carcinoma With Cirrhosis.

To evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Study Overview

Status

Unknown

Conditions

Detailed Description

Liver cancer is the fourth leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC) accounts for 70% to 85% of primary HCC and is the leading cause of death in patients with cirrhosis. We developed a novel no-touch combined directional perfusion radiofrequency ablation system.By inserting two or more electrodes around the tumor and activating them simultaneously.The hypertonic saline solution can be directed into the focal tissue from a lateral pore through a tube within the electrode to provide more uniform and thorough necrosis.The maximum ablation volume was increased while the loss of normal tissue in the non-injection direction was reduced, thus reducing the incidence of postoperative complications. Therefore, the purpose of this study was to evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Institute of hepatobiliary surgery,southwest hospital
      • Chongqing, Chongqing, China, 400038
        • Enrolling by invitation
        • Institute of hepatobiliary surgery,southwest hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary hepatocellular carcinoma with cirrhosis

Description

Inclusion Criteria:

  • Primary hepatocellular carcinoma with a background of cirrhosis
  • Single shot with diameter ≤ 3cm
  • The tumor did not invade portal vein, hepatic vein trunk and secondary branches
  • Child Pugh A/B
  • ICG-R15 ≤ 30%
  • 18-70 years old
  • The follow-up time reached 2 years

Exclusion Criteria:

  • The follow-up time is less than 2 years
  • multiple lesions or diameter > 3cm
  • Previous history of upper gastrointestinal bleeding or severe hypersplenism
  • Patients with extrahepatic or lymph node metastasis
  • Wish to receive liver transplantation and hepatectomy
  • The lesion is adjacent to the gallbladder, important blood vessels and bile ducts in the hilum of the liver and important organs around
  • severe bleeding tendency, platelet count < 50 × 10^9/L, or prothrombin time prolonged > 3s
  • Other anti-tumor therapies were accepted before surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of local tumor progression (LTP)
Time Frame: two-years local tumor progression-free survival
LTP was defined as the appearance of new tumor foci near 2 cm at the ablative margin after the local eradication of all tumor cells with RFA
two-years local tumor progression-free survival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor-free survival
Time Frame: two-years tumor-free survival
The tumor did not recur after treatment.
two-years tumor-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (ACTUAL)

August 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cstc2019jscx-msxmX0230

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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