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

Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arrhythmia; Respiratory Arrest

Intervention: Atropine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Arnulf Ferlitsch, MD, Principal Investigator, Affiliation: Medical University of Vienna

Summary

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.

Clinical Details

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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Occurrence of dysrhythmias

Secondary outcome: Clinical complications

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Div. of Gastroenterology and Hepatology, Medical University of Vienna, Vienna 1090, Austria
Additional Information

Related publications:

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
Ending date: January 2008
Last updated: January 23, 2008

Page last updated: June 20, 2008

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