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

Not Applicable

Recruiting

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution; Procedure: Hemostatic therapy

• Registration Number: NCT05353062
• Lead Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-04-29
• Status Verified: 2023-01
• Study Start: 2023-01-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard therapy	Endoscopic therapy with hemoclip +/- injection of epinephrine solution	Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Bipolar hemostatic forceps	Hemostatic therapy	Endoscopic therapy with bipolar hemostatic forceps

Primary Outcome Measures

Name	Time	Method
Rebleeding	30 days	Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Successful primary hemostasis	15 minutes	Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy

Secondary Outcome Measures

Name	Time	Method
Reinterventions	30 days	Number of endoscopic reinterventions for gastrointestinal bleeding

Trial Locations

Locations (1)

Helios Kliniken Schwerin; 🇩🇪 Schwerin, Germany