Irreversible Electroporation(IRE) For Unresectable Renal Tumors

Fuda Cancer Hospital, Guangzhou

Status: Completed

Conditions: Renal Tumor

Treatments: Procedure: irreversible electroporation

Study type: Interventional

Funder types: Other

Identifiers

NCT02335827

IRE-001

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

Full description

By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• unresectable kidney tumors
• patients refused surgical therapy
• Karnofsky-index >70%
• Age ≥ 18 and ≤ 80 years
• life expectancy ≥ 12 month
• compliance of the patient taking part in a study
• informed consent

Exclusion criteria

• violation against one or more inclusion criteria
• an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
• QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
• active infection or severe health interference, that make taking part in a study unfeasible
• pregnancy, lactation period
• general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
• psychiatric disorders that make taking part in a study or giving informed consent unfeasible
• haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
• thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
• untreated urinary retention
• severe hepatic dysfunction
• any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
• taking part in another clinical study for renal tumor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 3 patient groups

Group A

Experimental group

Description:

irreversible electroporation with voltage in level A for renal tumors

Treatment:

Procedure: irreversible electroporation

Group B

Experimental group

Description:

irreversible electroporation with voltage in level B for renal tumors

Treatment:

Procedure: irreversible electroporation

Group C

Experimental group

Description:

irreversible electroporation with voltage in level C for renal tumors

Treatment:

Procedure: irreversible electroporation