None listed
Conditions
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.
Interventions
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 aggregatio
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
Sponsors
Albert Ludwigs University Freiburg
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed