Irreversible Electroporation(IRE) For Unresectable Renal Tumors
NCT ID: NCT02335827
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2015-01-01
2021-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
irreversible electroporation with voltage in level A for renal tumors
irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Group B
irreversible electroporation with voltage in level B for renal tumors
irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Group C
irreversible electroporation with voltage in level C for renal tumors
irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Interventions
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irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Lizhi Niu, PHD
Role: STUDY_CHAIR
Fuda Cancer Hospital
Locations
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Fuda Cancer Hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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IRE-001
Identifier Type: -
Identifier Source: org_study_id
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