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

Sponsor

Theresienkrankenhaus und St. Hedwig-Klinik GmbH (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05353062

Collaborator

PENTAX Europe GmbH (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Hemorrhage	Procedure: Hemostatic therapy Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Randomized prospective studyRandomized prospective study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard therapy Endoscopic therapy with hemoclip +/- injection of epinephrine solution	Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Experimental: Bipolar hemostatic forceps Endoscopic therapy with bipolar hemostatic forceps	Procedure: Hemostatic therapy Bipolar hemostatic forceps

Arm

Intervention/Treatment

Active Comparator: Standard therapy

Endoscopic therapy with hemoclip +/- injection of epinephrine solution

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

Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Experimental: Bipolar hemostatic forceps

Endoscopic therapy with bipolar hemostatic forceps

Procedure: Hemostatic therapy

Bipolar hemostatic forceps

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Reinterventions [30 days]
Number of endoscopic reinterventions for gastrointestinal bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Theresienkrankenhaus und St. Hedwig-Klinik GmbH
PENTAX Europe GmbH

Investigators

Principal Investigator: Daniel Schmitz, MD, Helios Kliniken Schwerin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Theresienkrankenhaus und St. Hedwig-Klinik GmbH

ClinicalTrials.gov Identifier:

NCT05353062

Other Study ID Numbers:

BeBop01

First Posted:

Apr 29, 2022

Last Update Posted:

May 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Theresienkrankenhaus und St. Hedwig-Klinik GmbH

Hemostasis, Endoscopic; Randomized Controlled Trial

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Epinephrine

Hemostatics

Study Results

No Results Posted as of May 6, 2022