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

Gastrointestinal Hemorrhage Clinical Trial

— BeBop  

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 Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05353062
• Other study ID #: BeBop01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Contact: Daniel Schmitz, MD
• Phone: +491758674415
• Email: Daniel.Schmitz[@]helios-gesundheit.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Procedure:
• Hemostatic therapy
Bipolar hemostatic forceps
• Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Locations

Country	Name	City	State
Germany	Helios Kliniken Schwerin	Schwerin

Sponsors (2)

Lead Sponsor	Collaborator
Theresienkrankenhaus und St. Hedwig-Klinik GmbH	PENTAX Europe GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Gralnek IM, Stanley AJ, Morris AJ, Camus M, Lau J, Lanas A, Laursen SB, Radaelli F, Papanikolaou IS, Curdia Goncalves T, Dinis-Ribeiro M, Awadie H, Braun G, de Groot N, Udd M, Sanchez-Yague A, Neeman Z, van Hooft JE. Endoscopic diagnosis and management of — View Citation

Kataoka M, Kawai T, Hayama Y, Yamamoto K, Nonaka M, Aoki T, Yagi K, Fukuzawa M, Fukuzawa M, Moriyasu F. Comparison of hemostasis using bipolar hemostatic forceps with hemostasis by endoscopic hemoclipping for nonvariceal upper gastrointestinal bleeding in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful primary hemostasis	Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy	15 minutes
Primary	Rebleeding	Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy	30 days
Secondary	Reinterventions	Number of endoscopic reinterventions for gastrointestinal bleeding	30 days