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Trial registered on ANZCTR


Registration number
ACTRN12608000194369
Ethics application status
Not yet submitted
Date submitted
6/04/2008
Date registered
14/04/2008
Date last updated
14/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bleeding risk after percutaneous endoscopic gastrostomy (PEG) with simultaneous treatment of aggressive antithrombotic-drug regimens
Scientific title
A prospective Study in 1041 patients with percutaneous endoscopic gastrostomy analysing different antithrombotic drug regimes concerning bleeding risk and other complications
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bleeding risk after PEG with and without antithrombotic drug regimes 3003 0
risk of peritonitis after PEG with and without antithrombotic drug regimes 3004 0
risk of infection after PEG with and without antithrombotic drug regimes 3005 0
Condition category
Condition code
Surgery 3178 3178 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous Endoscopic Gastrostomie PEG : We used the classical PEG performed by the pull through technique in one-hand technique, our average duration of intervention was 4 minutes 30.The mean dose of Disoprivan® (Propofolum (2,6-Diisopropylphenol) used was 85 mg.Due to the in part high risk of thromboembolic complications in our neurological and stroke patients, and in patients with internal and external cardiac support devices, we opted generally not to withdraw the thrombocyte aggregation inhibitors ASA (Aspirin®; Bayer Schering Pharma, Berlin, Germany) and clopidogrel (Plavix®; Bristol-Myers Sanofi Pharmaceuticals Partnership, New-York, USA) or to interrupt unfractionated heparin (UFH; Liquemin®; Hoffmann-La Roche Pharma AG, Grenzach-Whylen, Germany) prior to PEG placement. Phenprocoumone (Marcumar®; Hoffmann-La Roche AG, Grenzach-Wyhlen; Germany) was also not defined as a contraindication
Intervention code [1] 2745 0
Treatment: Surgery
Comparator / control treatment
standard treatment PEG without any antithrombotic drug regimes
Control group
Active

Outcomes
Primary outcome [1] 4038 0
bleeding risk
Univariate logistic regression analysis was performed using the Pearson chi-squared test and the more exact Fisher test.
Timepoint [1] 4038 0
Clinical controls by members of the endoscopic team were made during the first 7 days after PEG placement and on the day of discharge
Primary outcome [2] 4039 0
peritonitis
Univariate logistic regression analysis was performed using the Pearson chi-squared test and the more exact Fisher test.
Timepoint [2] 4039 0
Clinical controls by members of the endoscopic team were made during the first 7 days after PEG placement and on the day of discharge
Primary outcome [3] 4040 0
infection
Univariate logistic regression analysis was performed using the Pearson chi-squared test and the more exact Fisher test.
Timepoint [3] 4040 0
Clinical controls by members of the endoscopic team were made during the first 7 days after PEG placement and on the day of discharge
Secondary outcome [1] 6801 0
follow up complication
Timepoint [1] 6801 0
Further controls or measures were made according to clinical need or twice a year. Six months after the end of the recruiting period (September 2007), all patients were contacted by telephone or a clinical course control was made

Eligibility
Key inclusion criteria
All 1057 patients referred between September 2001 and March 2007 to the endoscopic department of the Surgical Hospital at the University of Freiburg from in-house or external specialist departments (Neurology, Radiology, Clinic for Anesthesia, Cardiac Surgery and Orthodontic Surgery, ENT and Pediatrics and the International Medical Service -IMS) with the indication for percutaneous endoscopic gastrostomy (PEG) were enrolled according to predefined exclusion criteria

further criteria
cirrhosis
nicotinism
obesity
diabetes mellitus
coagulopathy
malignancy
neurological disorders
inflammatory disorders
radiation therapy
chemo therapy
alcoholism

ENT: Esopageal-Naso-Throat Hospital
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria were defined: Patients in whom no standard “pull-through” technique with or without prior Savary-Gilliard bouginage (SG-bouginage) in stenosis of the hypopharynx or esophagous was possible, patients in whom the PEG could not be placed without additional imaging (computer tomography), and patients in whom PEG placement had to be terminated prior to completion due to respiratory or other complications, or patients who died within the first 7 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 859 0
Germany
State/province [1] 859 0

Funding & Sponsors
Funding source category [1] 3264 0
University
Name [1] 3264 0
Albert Ludwigs University Freiburg
Address [1] 3264 0
Hugstetter Strasse 55
79106 Freiburg
Country [1] 3264 0
Germany
Primary sponsor type
University
Name
Albert Ludwigs University Freiburg
Address
Hugstetter Strasse 55
79106 Freiburg
Country
Germany
Secondary sponsor category [1] 2936 0
None
Name [1] 2936 0
Address [1] 2936 0
Country [1] 2936 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5249 0
ethic Committee of the Albert Ludwigs Univ. Freiburg
Ethics committee address [1] 5249 0
Ethics committee country [1] 5249 0
Germany
Date submitted for ethics approval [1] 5249 0
30/08/2007
Approval date [1] 5249 0
Ethics approval number [1] 5249 0
According to the vote of the Ethics Commission of the University of Freiburg, this study did not require approval by the Ethics Commission, since all treatments were undertaken based on a medical indication and no details were altered for study reasons during the assessment
Ethics committee name [2] 5269 0
Ethics committee address [2] 5269 0
Ethics committee country [2] 5269 0
Date submitted for ethics approval [2] 5269 0
30/08/2007
Approval date [2] 5269 0
Ethics approval number [2] 5269 0

Summary
Brief summary
PEG placement under the thrombocyte aggregation inhibitor aspirin (acetylsalicylacid; ASA) has been considered a relative contraindication thus far according to the ASGE guidelines, aggressive antithrombotic drug regimens or clopidogrel and phenprocoumon/warfarin in patients with high risk conditions like atrial fibrillation associated with valvular heart disease, mechanical valve in the mitral position and mechanical valve and prior thromboembolic event make this a high-risk procedure. The present study addresses for the first time the risk of bleeding and general complications of PEG in patients treated concurrently with simple or aggressive regimens of mono- or combination anticoagulants. The influence of the thrombocyte aggregation inhibitors ASA and clopidogrel is studied alone or in combination with low-molecular weight or unfractionated heparin or phenproucumone using a modified pull-through technique.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28496 0
Address 28496 0
Country 28496 0
Phone 28496 0
Fax 28496 0
Email 28496 0
Contact person for public queries
Name 11653 0
Andreas Fischer
Address 11653 0
Department of General and Viszeral Surgery
Hugstetter Strasse 55
79106 Freiburg
Country 11653 0
Germany
Phone 11653 0
0049 0761 270 2541
Fax 11653 0
Email 11653 0
andreas.fischer@uniklinik-freiburg.de
Contact person for scientific queries
Name 2581 0
Hans-Juergen Schrag
Address 2581 0
Department of General and Viszeral Surgery
Hugstetter Strasse 55
79106 Freiburg
Country 2581 0
Germany
Phone 2581 0
0049 0761 270 2542
Fax 2581 0
Email 2581 0
hans-juergen.schrag@t-online.de

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary