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

Not Applicable

• Conditions: Acute Upper Gastrointestinal Hemorrhage

• 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

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Last Update Submitted: 2013-04-17
• Study First Posted: 2013-04-22
• Last Update Posted: 2013-04-22
• Primary Completion: 2015-03
• Study Completion: 2015-04

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

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