Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
Not Applicable
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Interventions
- Device: Endoscopic hemostasis
- Registration Number
- NCT01836900
- Lead Sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Recurrence of bleeding from gastroduodenal ulcers
Exclusion Criteria
- Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard Therapy Endoscopic hemostasis Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution OTSC (Over The Scope Clip) Endoscopic hemostasis Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
- Primary Outcome Measures
Name Time Method Persistent bleeding or Rebleeding with 7 days 7 days
- Secondary Outcome Measures
Name Time Method Amount of endoscopic reinterventions 7 d blood units transfused 30 days duration of hospital stay 30 days duration of intensive care unit stay 30 days 30 d Mortality 30 days Necessity of surgical or angiographic therapy 7 d Complications during or after OTSC (Over The Scope Clip) placement 7 d
Trial Locations
- Locations (1)
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany