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Completed

NCT Number: NCT02335827

Irreversible Electroporation(IRE) For Unresectable Renal Tumors

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

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Key information

Conditions

Renal Tumor Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuda Cancer Hospital

Guangzhou, Guangdong, 510665, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

irreversible electroporation

Procedure

Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors

Primary outcomes

  1. adverse effects

    Time frame: 1 month

    adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.

  2. Quality of Life (QoL)

    Time frame: 2 months

    Quality of Life assessed as WHOQOL-BREF.

  3. procedural compliance

    Time frame: 3 months

    compliance will be analyzed by 3 months of follow-up post procedure.

Secondary outcomes

  1. Recurrence rate

    Time frame: 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.

  2. Voltage (A minimum and maximum range of voltage for safe and effective IRE)

    Time frame: 3 months

    A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

Other outcomes

  1. Progress free disease (PFS)

    Time frame: 12 months

    Patients will be followed for 12 months after IRE for PFS assessing.

  2. Overall survival (OS)

    Time frame: 36 months

    Patients will be followed for 36 months after IRE for OS analyzed.

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial

Acronym: IRE

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jan 12, 2015
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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