Status:
ACTIVE_NOT_RECRUITING
The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Liver Cancer
Ablation Techniques
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
Malignant liver tumors are among the most common cancers worldwide, with over 10,000 new cases reported annually in Taiwan. Despite the availability of various treatment options, the prognosis for pri...
Eligibility Criteria
Inclusion
- Malignant liver cancer including hepatocellular carcinoma (HCC), cholangiocarcinoma and metastatic liver cancers, The diagnosis of cholangiocarcinoma or metastatic liver cancers with pathologic proven, and the diagnosis of HCC will be made by pathology / cytology or according to the AASLD (2018) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either tri-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
- Unsuitable for surgical resection but local ablation is indicated, however, the distance between tumour and inferior vena cava, hepatic veins or bilateral; portal veins is smaller than 1 cm.
- The patient can tolerate endotracheal intubation and general anaesthesia.
- The tumour number is less than or equal to 3,
- Maximal tumor size must be ≤ 5 cm in diameter,
- Child-Pugh class A-B,
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- American Society of Anesthesiologists (ASA) score ≤ 3,
- Adequate bone marrow and liver function (1). PT-INR ≦ 2.0. (2). Platelet count ≥ 100 K/Μl (3). Total bilirubin ≦ 3 mg/dL (4). ALT and AST \< 5 x upper limit of normal
- Prior Informed Consent Form
- Life expectancy of at least 3 months.
Exclusion
- History of cardiac disease: (A)Congestive heart failure \>NYHA class 2; (B)Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening); (C)Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted)
- Immunotherapy or chemotherapy ≤ 6 weeks prior to the procedure;
- Contraindicated to abdominal CT and MRI
- Allergy to muscle relaxant.
- History of epilepsy
- Women who are pregnant or women of child-bearing potential without using an acceptable method of contraception,
- Patients received treatment with an investigational agent/ procedure within 30 days.
- Patients with hypertension or arrythmia under poor medical control
- Acute infection or inflammation, acute and severe dysfunction of heart, liver and kidney, and the patients with metallic implantation including pacemaker.
- Known history of HIV infection
- Concurrent extrahepatic cancer
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07214363
Start Date
October 1 2023
End Date
December 31 2026
Last Update
October 9 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100