Gastrointestinal HemorrhageBeBopNCT05353062
Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding
A study testing Hemostatic therapy and Endoscopic therapy with hemoclip +/- injection of epinephrine solution in people with Gastrointestinal Hemorrhage, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
Trial summary
Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Hemostatic therapy and Endoscopic therapy with hemoclip +/- injection of epinephrine solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active, nonvariceal, upper gastrointestinal bleeding
Who cannot join
- Severe coagulopathy unresponsive to blood products transfusions: platelets <20,000; international normalized ratio >3.0; partial thromboplastin time >2 normal
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Helios Kliniken Schwerin
Schwerin, 19055
Daniel Schmitz, MD, +491758674415, Daniel.Schmitz@helios-gesundheit.de
Martin Kliment, MD, +493855202601, Martin.Kliment@helios-gesundheit.de
About this study
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
Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial
Read the 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.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Hemostatic therapy, Endoscopic therapy with hemoclip +/- injection of epinephrine solution
- Keywords
- Hemostasis, Endoscopic; Randomized Controlled Trial
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic therapyProcedure or surgery
Bipolar hemostatic forceps
Endoscopic therapy with hemoclip +/- injection of epinephrine solutionProcedure or surgery
Endoscopic therapy with hemoclip +/- injection of epinephrine solution
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | Active comparator | Endoscopic therapy with hemoclip +/- injection of epinephrine solution Receives: Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solution |
| Bipolar hemostatic forceps | Experimental | Endoscopic therapy with bipolar hemostatic forceps Receives: Procedure: Hemostatic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful primary hemostasis
Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Measured: 15 minutes
Rebleeding
Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Measured: 30 days
Secondary outcomes (1)
Reinterventions
Number of endoscopic reinterventions for gastrointestinal bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized prospective study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- PENTAX Europe GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Schmitz, MD, Principal investigator, Helios Kliniken Schwerin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353062
- Sponsor's protocol ID
- BeBop01
- Acronym
- BeBop
- Status last verified
- Jan 2023
- First submitted
- 25 Apr 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be available to other researchers on request
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.
PubMed 33567467Kataoka 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.
PubMed 23468331Schmitz 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.
PubMed 37322511
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05353062
- Acronym / sponsor ID
- BeBop / BeBop01
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- Hemostasis, Endoscopic; Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity, hospital or other
- Collaborators
- PENTAX Europe GmbH
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | Active comparator | Procedure: Endoscopic therapy with hemoclip +/- injection of epinephrine solutionEndoscopic therapy with hemoclip +/- injection of epinephrine solution |
| Bipolar hemostatic forceps | Experimental | Procedure: Hemostatic therapyEndoscopic therapy with bipolar hemostatic forceps |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active, nonvariceal, upper gastrointestinal bleeding
Key exclusion criteria (1 listed)
- Severe coagulopathy unresponsive to blood products transfusions: platelets <20,000; international normalized ratio >3.0; partial thromboplastin time >2 normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemostatic therapyBipolar hemostatic forceps | Procedure or surgery | Bipolar hemostatic forceps |
| Endoscopic therapy with hemoclip +/- injection of epinephrine solutionEndoscopic therapy with hemoclip +/- injection of epinephrine solution | Procedure or surgery | Standard therapy |
Primary outcome
Successful primary hemostasis
Time frame: 15 minutes
Number of participants without further endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
Rebleeding
Time frame: 30 days
Number of participants without recurrent endoscopically visible gastrointestinal bleeding in esophagogastroduodonoscopy
1 secondary outcome
Reinterventions
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Results publication: PubMed 33567467Gralnek 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 publication: PubMed 23468331Kataoka 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.
- Derived from this study: PubMed 37322511Schmitz 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be available to other researchers on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Schmitz, MD principal investigator
Helios Kliniken Schwerin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic therapy and Endoscopic therapy with hemoclip +/- injection of epinephrine solution in people with Gastrointestinal Hemorrhage, run by Theresienkrankenhaus und St. Hedwig-Klinik GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Schmitz, MD (+491758674415, Daniel.Schmitz@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful primary hemostasis (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353062, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.