Clinical Trial: Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Bipolar Hemostatic Forceps Versus Standard Therapy by Hemoclip and or Epinephrin Injection as Initial Endoscopic Treatment in Acute Non-variceal Upper GI Bleeding: a Prospective, Randomized Multicente

Brief Summary: Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial

Detailed Summary: 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.
Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Current Primary Outcome: Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy

Original Primary Outcome: Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Dates:
Date Received: April 25, 2022
Date Started: January 01, 2023
Date Completion: February 01, 2024
Last Updated: January 25, 2023
Last Verified: January 01, 2023