Acute Upper Gastrointestinal Hemorrhage
Conditions
Keywords
OTSC, Upper gastrointestinal bleeding
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.
Interventions
DEVICEEndoscopic hemostasis
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
Sponsors
University Hospital Tuebingen
University Hospital Augsburg
Marienkrankenhaus Frankfurt
Klinikum Stadt Hanau
Klinikum Garmisch-Patenkirchen
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
Kliniken Ludwigsburg-Bietigheim gGmbH
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Persistent bleeding or Rebleeding with 7 days | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| duration of hospital stay | 30 days |
| duration of intensive care unit stay | 30 days |
| 30 d Mortality | 30 days |
| blood units transfused | 30 days |
| Necessity of surgical or angiographic therapy | 7 d |
| Complications during or after OTSC (Over The Scope Clip) placement | 7 d |
| Amount of endoscopic reinterventions | 7 d |
Countries
Germany
Contacts
Primary ContactKarel Caca, Prof. Dr.
Backup ContactArthur Schmidt, Dr.
Outcome results
None listed