NCT05353062

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

April 25, 2022

Last Update Submit

January 25, 2023

Conditions

Gastrointestinal Hemorrhage

Keywords

Hemostasis, Endoscopic; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Reinterventions

    30 days

Study Arms (2)

Standard therapy

ACTIVE COMPARATOR

Endoscopic therapy with hemoclip +/- injection of epinephrine solution

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

Bipolar hemostatic forceps

EXPERIMENTAL

Endoscopic therapy with bipolar hemostatic forceps

Procedure: Hemostatic therapy

Interventions

Hemostatic therapyPROCEDURE

Bipolar hemostatic forceps

Bipolar hemostatic forceps
Endoscopic therapy with hemoclip +/- injection of epinephrine solutionPROCEDURE

Endoscopic therapy with hemoclip +/- injection of epinephrine solution

Standard therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active, nonvariceal, upper gastrointestinal bleeding

You may not qualify if:

  • Severe coagulopathy unresponsive to blood products transfusions: platelets \<20,000; international normalized ratio \>3.0; partial thromboplastin time \>2 normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Kliniken Schwerin

Schwerin, 19055, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 33567467RESULT

  • 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.

    PMID: 23468331RESULT

  • Schmitz D, Thielemann L, Grassmann F. Bipolar haemostatic forceps versus standard therapy by haemoclip + / - epinephrine injection as initial endoscopic treatment in active non-variceal upper GI bleeding: study protocol for a prospective, randomized multicentre trial (BeBop-Trial). Trials. 2023 Jun 15;24(1):407. doi: 10.1186/s13063-023-07394-x.

    PMID: 37322511DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Schmitz, MD

    Helios Kliniken Schwerin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Schmitz, MD

CONTACT

+491758674415Daniel.Schmitz@helios-gesundheit.de

Martin Kliment, MD

CONTACT

+493855202601Martin.Kliment@helios-gesundheit.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Randomized prospective study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

January 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will be available to other researchers on request

Locations

DE(1)