Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score \> 6) and randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. 100 Patients are planned. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
OTSC placement
endoscopic standard therapy (two methods, e.g. clip and injection)
Klinikum Ludwigsburg
Ludwigsburg, Germany
RECRUITINGPersistent bleeding or Rebleeding with 7 days
Time frame: 7 days
blood units transfused
Time frame: 30 days
duration of hospital stay
Time frame: 30 days
duration of intensive care unit stay
Time frame: 30 days
30 d Mortality
Time frame: 30 days
Amount of endoscopic reinterventions
Time frame: 7 days
Necessity of surgical or angiographic therapy
Time frame: 7 days
Complications during or after OTSC (Over The Scope Clip) placement
Time frame: 7 days
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