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| Name | Class |
|---|---|
| University Hospital Tuebingen | OTHER |
| University Hospital Augsburg | OTHER |
| Marienkrankenhaus Frankfurt | OTHER |
| Klinikum Stadt Hanau |
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Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Therapy | Active Comparator | Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution |
|
| OTSC (Over The Scope Clip) | Experimental | Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic hemostasis | Device | Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent bleeding or Rebleeding with 7 days | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| blood units transfused | 30 days | |
| duration of hospital stay | 30 days | |
| duration of intensive care unit stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karel Caca, Prof. Dr. | Contact | +49714167201 | karel.caca@kliniken-lb.de | |
| Arthur Schmidt, Dr. | Contact | +49714167201 | arthur.schmidt@kliniken-lb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Recruiting | Ludwigsburg | 71640 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29803838 | Derived | Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24. |
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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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| ID | Term |
|---|---|
| D016558 | Hemostasis, Endoscopic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
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| OTHER |
| Klinikum Garmisch-Patenkirchen | OTHER |
| University of Zurich | OTHER |
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
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| 30 days |
| 30 d Mortality | 30 days |
| Amount of endoscopic reinterventions | 7 d |
| Necessity of surgical or angiographic therapy | 7 d |
| Complications during or after OTSC (Over The Scope Clip) placement | 7 d |
| D013568 |
| Pathological Conditions, Signs and Symptoms |