Clinical trial · Interventional
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arrhythmia | — | UNRESOLVED | — |
| Respiratory Arrest | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atropine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1: Atropine
- description
- Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.
- interventionNames
- Drug: Atropine
- type
- PLACEBO_COMPARATOR
- label
- 2: Placebo
- description
- 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Occurrence of dysrhythmias
- timeFrame
- during percutaneous ethanol instillation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDFerlitsch 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. doi: 10.1111/j.1365-2362.2004.01321.x. PMID 15025681
- DERIVEDArnulf F, Monika S, Herwig S, Monika H, Johannes PD, Gregor U, Alfred G, Markus PR. Atropine for prevention of cardiac dysrhythmias in patients with hepatocellular carcinoma undergoing percutaneous ethanol instillation: a randomized, placebo-controlled, double-blind trial. Liver Int. 2009 May;29(5):715-20. doi: 10.1111/j.1478-3231.2008.01905.x. Epub 2008 Oct 27. PMID 19018977