Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy

Brief Summary

Official Title: “Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy”

Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied by clinical complications such as unconsciousness, respiratory arrest or seizure like symptoms. Study purpose is to evaluate whether the use of i.v. Atropine before starting ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized, placebo controlled, double blinded study. Atropine or saline solution will be administered intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A 6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal possibly occurring dysrhythmias.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Interventions Used in this Clinical Trial

  • Drug: Atropine
    • Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.
  • Drug: Placebo
    • 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1: Atropine
    • Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.
  • Placebo Comparator: 2: Placebo
    • 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Outcome Measures for this Clinical Trial

Primary Measures

  • Occurrence of dysrhythmias
    • Time Frame: during percutaneous ethanol instillation
      Safety Issue?: Yes

Secondary Measures

  • Clinical complications
    • Time Frame: during percutaneous ethanol instillation and consecutive 24 hours
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation

Exclusion Criteria

  • contraindication for the administration of atropine like
  • narrow angle glaucoma
  • mechanic stenoses of the GI-tract
  • clinically relevant prostatic hypertrophy
  • paralytic ileus
  • myasthenia gravis
  • severe cerebral sclerosis
  • acute lung edema
  • acute myocardial infarction
  • cardiac insufficiency
  • hyperthyroidism
  • patients with contraindication to undergo percutaneous ethanol instillation

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Arnulf Ferlitsch, MD, Gastroenterology and Hepatology, Medical University of Vienna
  • Overall Official(s)
    • Arnulf Ferlitsch, MD, Principal Investigator, Medical University of Vienna

References

Ferlitsch A, Kreil A, Bauer E, Schmidinger H, Schillinger M, Gangl A, Peck-Radosavljevic M. Bradycardia and sinus arrest during percutaneous ethanol injection therapy for hepatocellular carcinoma. Eur J Clin Invest. 2004 Mar;34(3):218-23.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00575523