Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial
Patients with active, non-variceal, upper gastrointestinal bleeding usually need an urgent endoscopic treatment. The standard therapy by application of an hemoclip and/or injection of an epinephrine solution is not always successful. Bipolar hemostatic forceps is already being used successfully for the treatment of gastrointestinal bleeding in endoscopic submucosal dissection. Its use in primary endoscopic treatment of non-variceal, upper gastrointestinal bleeding has not been shown yet in a randomized prospective study. Patients with active, non-variceal, upper gastrointestinal bleeding (esophagus or stomach or duodenum) of any cause are randomized (1:1) in standard therapy by combination therapy using an hemoclip and/or injection of an epinephrine solution or experimental therapy by application of the bipolar hemostatic forceps. Cross over-treatment should be tried first in case of failed initial treatment. Rescue treatment by other methods such as application of an Over the Scope Clip (OTSC), angiographic embolization or surgery will be allowed next. All patients receive an additional standard therapy by proton pump inhibitors (PPI). Hypothesis: Endoscopic therapy by application of the bipolar hemostatic forceps is superior to standard therapy regarding technical success and rebleeding rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Bipolar hemostatic forceps
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Helios Kliniken Schwerin
Schwerin, Germany
RECRUITINGSuccessful primary hemostasis
Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Time frame: 15 minutes
Rebleeding
Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Time frame: 30 days
Reinterventions
Number of endoscopic reinterventions for gastrointestinal bleeding
Time frame: 30 days
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