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

Not Applicable

• Conditions: Acute Upper Gastrointestinal Hemorrhage
• Interventions: Device: OTSC; Device: Endoscopic Standard therapy (combining two methods)

• Registration Number: NCT03331224
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTSC	OTSC	Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
Standard therapy	Endoscopic Standard therapy (combining two methods)	Endoscopic standard therapy (two techniques e.g. clip and injection)

Primary Outcome Measures

Name	Time	Method
Persistent bleeding or Rebleeding with 7 days	7 days

Secondary Outcome Measures

Name	Time	Method
blood units transfused	30 days
duration of hospital stay	30 days
duration of intensive care unit stay	30 days
30 d Mortality	30 days
Amount of endoscopic reinterventions	7 days
Necessity of surgical or angiographic therapy	7 days
Complications during or after OTSC (Over The Scope Clip) placement	7 days

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany