Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding (BeBop)
Primary Purpose
Gastrointestinal Hemorrhage
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hemostatic therapy
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Hemorrhage focused on measuring Hemostasis, Endoscopic; Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
- Helios Kliniken SchwerinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard therapy
Bipolar hemostatic forceps
Arm Description
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Endoscopic therapy with bipolar hemostatic forceps
Outcomes
Primary Outcome Measures
Successful primary hemostasis
Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Rebleeding
Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Secondary Outcome Measures
Reinterventions
Number of endoscopic reinterventions for gastrointestinal bleeding
Full Information
NCT ID
NCT05353062
First Posted
April 25, 2022
Last Updated
January 25, 2023
Sponsor
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Collaborators
PENTAX Europe GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05353062
Brief Title
Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theresienkrankenhaus und St. Hedwig-Klinik GmbH
Collaborators
PENTAX Europe GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
Hemostasis, Endoscopic; Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Randomized prospective study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Arm Title
Bipolar hemostatic forceps
Arm Type
Experimental
Arm Description
Endoscopic therapy with bipolar hemostatic forceps
Intervention Type
Procedure
Intervention Name(s)
Hemostatic therapy
Intervention Description
Bipolar hemostatic forceps
Intervention Type
Procedure
Intervention Name(s)
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Intervention Description
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
Primary Outcome Measure Information:
Title
Successful primary hemostasis
Description
Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Time Frame
15 minutes
Title
Rebleeding
Description
Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Reinterventions
Description
Number of endoscopic reinterventions for gastrointestinal bleeding
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Schmitz, MD
Phone
+491758674415
Email
Daniel.Schmitz@helios-gesundheit.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Kliment, MD
Phone
+493855202601
Email
Martin.Kliment@helios-gesundheit.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Schmitz, MD
Organizational Affiliation
Helios Kliniken Schwerin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Kliniken Schwerin
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Schmitz, MD
Phone
+491758674415
Email
Daniel.Schmitz@helios-gesundheit.de
First Name & Middle Initial & Last Name & Degree
Martin Kliment, MD
Phone
+493855202601
Email
Martin.Kliment@helios-gesundheit.de
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will be available to other researchers on request
Citations:
PubMed Identifier
33567467
Citation
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 nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021 Mar;53(3):300-332. doi: 10.1055/a-1369-5274. Epub 2021 Feb 10.
Results Reference
result
PubMed Identifier
23468331
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 a prospective non-randomized trial. Surg Endosc. 2013 Aug;27(8):3035-8. doi: 10.1007/s00464-013-2860-4. Epub 2013 Mar 7.
Results Reference
result
Learn more about this trial
Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding
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