NCT02332551

Percutaneous Irreversible Electroporation to Treat Liver Cancer Close to the Gallbladder

A Prospective Clinical Trial Using Irreversible Electroporation (IRE) for the Treatment of Unresectable Hepatic Carcinoma Close to the Gallbladder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fuda Cancer Hospital, Guangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable Hepatic carcinoma close to the gallbladder, also Progress Free Survival (PFS) will be recorded.

Detailed description

Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

Conditions

• Hepatic Carcinoma

Interventions

Type	Name	Description
DEVICE	NanoKnife	Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder .

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-12-01
• Completion: 2021-08-01
• First posted: 2015-01-07
• Last updated: 2021-09-05

Locations

1 site across 1 country: China