NCT00575523

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

January 25, 2008

Status Verified

January 1, 2008

First QC Date

December 17, 2007

Last Update Submit

January 23, 2008

Conditions

ArrhythmiaRespiratory Arrest

Keywords

atropinepercutaneous ethanol instillationhepatomabradycardiaarrhythmia

Outcome Measures

Primary Outcomes (1)

  • Occurrence of dysrhythmias

    during percutaneous ethanol instillation

Secondary Outcomes (1)

  • Clinical complications

    during percutaneous ethanol instillation and consecutive 24 hours

Study Arms (2)

1: Atropine

ACTIVE COMPARATOR

Atropine 0,5mg is administered intravenously immediately before starting percutaneous ethanol instillation.

Drug: Atropine

2: Placebo

PLACEBO COMPARATOR

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

Drug: Placebo

Interventions

AtropineDRUG

Atropine 0,5mg is administered once intravenously immediately before starting percutaneous ethanol instillation.

1: Atropine
PlaceboDRUG

1ml 0,9% Saline solution is administered intravenously immediately before starting percutaneous ethanol instillation.

2: Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hepatoma scheduled for treatment with percutaneous ethanol instillation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div. of Gastroenterology and Hepatology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

  • 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.

    PMID: 15025681BACKGROUND

  • 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.

    PMID: 19018977DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacApneaCarcinoma, HepatocellularBradycardia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Arnulf Ferlitsch, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 18, 2007

Study Start

October 1, 2003

Study Completion

January 1, 2008

Last Updated

January 25, 2008

Record last verified: 2008-01

Locations

AU(1)