Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy (STING)

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Unknown

Conditions: Acute Upper Gastrointestinal Hemorrhage

Treatments: Device: Endoscopic hemostasis

Study type: Interventional

Funder types: Other

Identifiers

NCT01836900

STING

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Standard Therapy

Active Comparator group

Description:

Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution

Treatment:

Device: Endoscopic hemostasis

OTSC (Over The Scope Clip)

Experimental group

Description:

Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution

Treatment:

Device: Endoscopic hemostasis