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

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Hemorrhage
• Intervention / Treatment: Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution; Procedure: Hemostatic therapy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Schmitz, MD; Phone Number: +491758674415; Email: Daniel.Schmitz@helios-gesundheit.de
• Study Contact Backup: Name: Martin Kliment, MD; Phone Number: +493855202601; Email: Martin.Kliment@helios-gesundheit.de

Study Locations

• Germany
  • Schwerin, Germany, 19055
    • Recruiting
    • Helios Kliniken Schwerin
    • Contact: Daniel Schmitz, MD; Phone Number: +491758674415; Email: Daniel.Schmitz@helios-gesundheit.de
    • Contact: Martin Kliment, MD; Phone Number: +493855202601; Email: Martin.Kliment@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful primary hemostasis	Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy	15 minutes
Rebleeding	Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reinterventions	Number of endoscopic reinterventions for gastrointestinal bleeding	30 days

Collaborators and Investigators

• Sponsor: Theresienkrankenhaus und St. Hedwig-Klinik GmbH
• Collaborators: PENTAX Europe GmbH
• Investigators: Principal Investigator: Daniel Schmitz, MD, Helios Kliniken Schwerin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): January 27, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hemostasis, Endoscopic; Randomized Controlled Trial
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Coagulants; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Hemostatics; Epinephrine
• Other Study ID Numbers: BeBop01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data (IPD) will be available to other researchers on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No