Clinical trial NCT02567734: Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors
Official title: Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors：The Safety and Efficacy Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Carcinoma
Keywords: irreversible electroporation
ablation
neoplasms
cancer
carcinoma
NanoKnife
Ablation Techniques
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE） in the treatment of patients with locally advanced tumors in different anatomical position.

Detailed description: This study is a multicenter, open-label trial that aimed to evaluate the safety and efficacy of CT-guided percutaneous irreversible electroporation（IRE）in the treatment of patients with locally advanced tumors. Investigators will screen eligible patients and examine them by imaging tests as well as serological examination before and after the IRE procedures to assess the result with the size，blood supply，metabolism of tumors，the change of blood test and treatment-related complications. Big bore multislice spiral CT with thickness 5 cm, 120kilovolt，and 250milliampere，ECG-gated device and anesthesia monitoring equipment were selected during these procedures. Imaging (performed by contrast enhanced CT scan) and serological follow-up was at postoperative day 3 and 1，3，6，12months. The primary endpoint is the effective rate of IRE，and the secondary endpoint is 1-year survival rate and the frequency of adverse events. The response of irreversible electroporation ablation will be assessed according to the different evaluation criterions based on Response Evaluation Criteria in Solid Tumors.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed locally advanced solid tumor.
2. Unresectable tumors or the patient refused surgical therapy.
3. Patients in good health conditions can receive general anesthesia.
4. Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.

Exclusion Criteria:

1. Targeted tissues that metallic wallstents or metallics were implanted.
2. With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
3. With bleeding and psychiatric disorders.
4. Severe arrhythmia.

Primary outcomes:
measure: effective rate of IRE ablation
timeFrame: up to 12 months after the procedures
Secondary outcomes:
measure: 1-year survival rates
timeFrame: up to 12 months after the procedures
measure: complication rate
timeFrame: During the procedure or up to 12 months after the ablation procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Chinese PLA General Hospital
Study officials:
affiliation: The Chinese PLA General Hospital
name: Yueyong Xiao
role: PRINCIPAL_INVESTIGATOR
References: