A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer

March 15, 2020 updated by: Tian'an Jiang, First Affiliated Hospital of Zhejiang University
This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prospective, multi-center, single-arm clinical trial is to evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 190 subjects. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the effective rate of nanosecond knife ablation for liver cancer) and secondary outcomes (partial response rate, secondary ablation rate, progression-free survival, overall survival rate, quality of life score, alpha-fetoprotein levels, technical success rate, local control rate, complication rate, device Use satisfaction of nanosecond knife ablation for liver cancer). The first 2-month follow-up after the operation, CT, MR, CEUS, liver function, tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 2 to 3 months. After two years, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 3 to 6 months. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

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

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
  2. Age: 18-75 years old, regardless of gender.
  3. Liver function: Child-Pugh A or B, or Child C will reach B.
  4. No serious heart, lung, brain and other organ dysfunction. Normal or nearly normal blood coagulation function. Prothrombin time does not exceed 50% of the normal control, and platelets are more than 50 × 109 / L.
  5. It is usually suitable for single tumor with a maximum diameter of ≤5cm, or the number of tumors of ≤3 and a maximum diameter of ≤3cm.
  6. For single tumors > 5 cm in diameter that cannot be surgically removed, or multiple tumors with a maximum diameter > 3 cm, local ablation can be used as p palliative comprehensive treatment.
  7. According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
  8. Patients signed informed consent to participate in the trial.

Exclusion Criteria:

  1. The lesion of liver cancer is huge or diffuse ;
  2. Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
  3. tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
  4. liver function: Child-pugh C, those could not improve after liver protective treatment;
  5. Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
  6. Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
  7. Refractory large amount of ascites and cachexia;
  8. active infection, especially inflammation of the biliary system;
  9. Severe failure of major organs such as liver, kidney, heart, lung and brain;
  10. Patients with unconsciousness or unable to cooperate with treatment;
  11. Subjects could not be followed up and fell off;
  12. Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nanosecond knife group
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
Procedure: nanosecond knife liver cancer ablation
This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness analysis
Time Frame: 12 months
The effective rate of nanosecond knife ablation for liver cancer
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary validity analysis
Time Frame: 12 months
partial response rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
secondary ablation rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
progression-free survival of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
overall survival rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
quality of life score of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
alpha-fetoprotein levels
12 months
Secondary validity analysis
Time Frame: 12 months
technical success rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
local control rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
complication rate of nanosecond knife ablation for liver cancer
12 months
Secondary validity analysis
Time Frame: 12 months
device Use satisfaction of nanosecond knife ablation for liver cancer
12 months

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital of Zhejiang University

Collaborators

The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Xinjiang Medical University
Shulan (Hangzhou) Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nanosecond001
  • nanosecond knife01 (REGISTRY: nanosecond knife tumor ablation for liver cancer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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