Irreversible Electroporation(IRE) For Unresectable Renal Tumors

Not Applicable

Completed

• Conditions: Renal Tumor
• Interventions: Procedure: irreversible electroporation

• Registration Number: NCT02335827
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief Summary

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

Detailed 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 .

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-01-02
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2020-05-20
• Status Verified: 2020-06
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	irreversible electroporation	irreversible electroporation with voltage in level B for renal tumors
Group C	irreversible electroporation	irreversible electroporation with voltage in level C for renal tumors
Group A	irreversible electroporation	irreversible electroporation with voltage in level A for renal tumors

Primary Outcome Measures

Name	Time	Method
adverse effects	1 month	adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Quality of Life (QoL)	2 months	Quality of Life assessed as WHOQOL-BREF.
procedural compliance	3 months	compliance will be analyzed by 3 months of follow-up post procedure.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	12 months	efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination.
Voltage (A minimum and maximum range of voltage for safe and effective IRE)	3 months	A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

Trial Locations

Locations (1)

Fuda Cancer Hospital; 🇨🇳 Guangzhou, Guangdong, China