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| Name | Class |
|---|---|
| PENTAX Europe GmbH | INDUSTRY |
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Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | Active Comparator | Endoscopic therapy with hemoclip +/- injection of epinephrine solution |
|
| Bipolar hemostatic forceps | Experimental | Endoscopic therapy with bipolar hemostatic forceps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostatic therapy | Procedure | Bipolar hemostatic forceps |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reinterventions | Number of endoscopic reinterventions for gastrointestinal bleeding | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Schmitz, MD | Contact | +491758674415 | Daniel.Schmitz@helios-gesundheit.de | |
| Martin Kliment, MD | Contact | +493855202601 | Martin.Kliment@helios-gesundheit.de |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Schmitz, MD | Helios Kliniken Schwerin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Kliniken Schwerin | Recruiting | Schwerin | 19055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33567467 | Result | 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. | |
| 23468331 |
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Individual participant data (IPD) will be available to other researchers on request
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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Randomized prospective study
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| Endoscopic therapy with hemoclip +/- injection of epinephrine solution |
| Procedure |
Endoscopic therapy with hemoclip +/- injection of epinephrine solution |
|
| Result |
| 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. |
| 37322511 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |