Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arrhythmia; Respiratory Arrest
Intervention: Atropine (Drug); Placebo (Drug)
Phase: Phase 4
Sponsored by: Medical University of Vienna
Official(s) and/or principal investigator(s):
Arnulf Ferlitsch, MD, Principal Investigator, Affiliation: Medical University of Vienna
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.
Official title: Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Occurrence of dysrhythmias
Secondary outcome: Clinical complications
Minimum age: 18 Years.
Maximum age: N/A.
- Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation
- 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
- patients with contraindication to undergo percutaneous ethanol instillation
Locations and Contacts
Div. of Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria
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.
Starting date: October 2003
Last updated: January 23, 2008