Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding (BeBop)

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Status: Enrolling

Conditions: Gastrointestinal Hemorrhage

Treatments: Procedure: Hemostatic therapy; Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05353062

BeBop01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active, nonvariceal, upper gastrointestinal bleeding

Exclusion criteria

• Severe coagulopathy unresponsive to blood products transfusions: platelets <20,000; international normalized ratio >3.0; partial thromboplastin time >2 normal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard therapy

Active Comparator group

Description:

Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Treatment:

Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Bipolar hemostatic forceps

Experimental group

Description:

Endoscopic therapy with bipolar hemostatic forceps

Treatment:

Procedure: Hemostatic therapy