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| Name | Class |
|---|---|
| University Hospital Freiburg | OTHER |
| University Hospital Ulm | OTHER |
| University Hospital Goettingen | OTHER |
| Evangelisches Krankenhaus Düsseldorf |
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Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and 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.
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score > 6) and randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. 100 Patients are planned. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTSC | Experimental | Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency. |
|
| Standard therapy | Active Comparator | Endoscopic standard therapy (two techniques e.g. clip and injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTSC | Device | OTSC placement |
| |
| Endoscopic Standard therapy (combining two methods) |
| 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 | Contact | 004971419967201 | karel.caca@kliniken-lb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Recruiting | Ludwigsburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35321938 | Derived | Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, Wedi E, Zachaus M, Pickartz T, Kullmer A, Schmidt A, Caca K. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2). Gut. 2022 Jul;71(7):1251-1258. doi: 10.1136/gutjnl-2021-325300. Epub 2022 Mar 23. |
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| OTHER |
| University Hospital, Essen | OTHER |
| University of Leipzig | OTHER |
| University Hospital Tuebingen | OTHER |
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| Device |
endoscopic standard therapy (two methods, e.g. clip and injection) |
|
| 30 days |
| 30 d Mortality | 30 days |
| Amount of endoscopic reinterventions | 7 days |
| Necessity of surgical or angiographic therapy | 7 days |
| Complications during or after OTSC (Over The Scope Clip) placement | 7 days |