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

Acute Upper Gastrointestinal Hemorrhage Clinical Trial

— STING2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331224
• Other study ID #: STING2
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: October 31, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2017
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: Karel Caca, Prof
• Phone: 004971419967201
• Email: karel.caca[@]kliniken-lb.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• OTSC
OTSC placement
• Endoscopic Standard therapy (combining two methods)
endoscopic standard therapy (two methods, e.g. clip and injection)

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (8)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH	Evangelisches Krankenhaus Düsseldorf, University Hospital Freiburg, University Hospital Goettingen, University Hospital Tuebingen, University Hospital Ulm, University Hospital, Essen, University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent bleeding or Rebleeding with 7 days		7 days
Secondary	blood units transfused		30 days
Secondary	duration of hospital stay		30 days
Secondary	duration of intensive care unit stay		30 days
Secondary	30 d Mortality		30 days
Secondary	Amount of endoscopic reinterventions		7 days
Secondary	Necessity of surgical or angiographic therapy		7 days
Secondary	Complications during or after OTSC (Over The Scope Clip) placement		7 days