Status:
UNKNOWN
A Prospective, Multicenter Clinical Trial of Safety and Effectiveness of Nanosecond Knife Ablation for Liver Cancer
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Shulan (Hangzhou) Hospital
The First Affiliated Hospital of Zhengzhou University
Conditions:
Liver Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 partici...
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 na...
Eligibility Criteria
Inclusion
- Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
- Age: 18-75 years old, regardless of gender.
- Liver function: Child-Pugh A or B, or Child C will reach B.
- 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.
- 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.
- 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.
- According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.
- Patients signed informed consent to participate in the trial.
Exclusion
- The lesion of liver cancer is huge or diffuse ;
- Merged portal vein to secondary branch tumor thrombus or hepatic vein tumor thrombus, invasion of nearby organs or distant metastasis;
- tumors located on the surface of the liver, of which more than 1/3 tumor size are bare;
- liver function: Child-pugh C, those could not improve after liver protective treatment;
- Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment;
- Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding;
- Refractory large amount of ascites and cachexia;
- active infection, especially inflammation of the biliary system;
- Severe failure of major organs such as liver, kidney, heart, lung and brain;
- Patients with unconsciousness or unable to cooperate with treatment;
- Subjects could not be followed up and fell off;
- Those who discontinued treatment, or the case records were incomplete for various reasons, and were determined by researchers to be unable to be evaluated.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04309747
Start Date
April 1 2020
End Date
December 1 2022
Last Update
March 17 2020
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