An interventional study of Hemostatic therapy and Endoscopic therapy with hemoclip +/- injection of epinephrine solution in Gastrointestinal Hemorrhage, sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-27.
Sponsored by Theresienkrankenhaus und St. Hedwig-Klinik GmbH · Not applicable, Interventional, and Treatment
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 80 is close to the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Theresienkrankenhaus und St. Hedwig-Klinik GmbH is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Endoscopic therapy with bipolar hemostatic forceps
Procedure: Hemostatic therapy
Bipolar hemostatic forceps
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Successful 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
Plan to share: No — Individual participant data (IPD) will be available to other researchers on request
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Theresienkrankenhaus und St. Hedwig-Klinik GmbH