Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT02567734
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.
Study:
NCT02567734
Study Brief:
Protocol Section:
NCT02567734