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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Atropine | Active Comparator | Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation. |
|
| 2: Placebo | Placebo Comparator | 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dysrhythmias | during percutaneous ethanol instillation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complications | during percutaneous ethanol instillation and consecutive 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnulf Ferlitsch, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Div. of Gastroenterology and Hepatology, Medical University of Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15025681 | Background | 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. doi: 10.1111/j.1365-2362.2004.01321.x. | |
| 19018977 | Derived | Arnulf 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. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001049 | Apnea |
| D006528 | Carcinoma, Hepatocellular |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | 1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation. |
|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |