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

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Unknown

Conditions: Acute Upper Gastrointestinal Hemorrhage

Treatments: Device: Endoscopic Standard therapy (combining two methods); Device: OTSC

Study type: Interventional

Funder types: Other

Identifiers

NCT03331224

STING2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

OTSC

Experimental group

Description:

Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.

Treatment:

Device: OTSC

Standard therapy

Active Comparator group

Description:

Endoscopic standard therapy (two techniques e.g. clip and injection)

Treatment:

Device: Endoscopic Standard therapy (combining two methods)