Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)

Conditions
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Acute Upper Gastrointestinal Hemorrhage

Intervention / Treatment
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* Device: OTSC
* Device: Endoscopic Standard therapy (combining two methods)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: upper GI-bleeding (non-variceal) with high risk of recurrency 18 years and older Exclusion Criteria: variceal-bleeding under 18 years pregnancy or nursing period malignancy need for surgical treatment (for example perforation with peritonitis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTSC<br>Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency. | Device: OTSC<br>* OTSC placement<br>|
| Active Comparator: Standard therapy<br>Endoscopic standard therapy (two techniques e.g. clip and injection) | Device: Endoscopic Standard therapy (combining two methods)<br>* endoscopic standard therapy (two methods, e.g. clip and injection)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent bleeding or Rebleeding with 7 days |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood units transfused |  | 30 days | 
| duration of hospital stay |  | 30 days | 
| duration of intensive care unit stay |  | 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 |