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

Acute Upper Gastrointestinal Hemorrhage Clinical Trial

— STING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01836900
• Other study ID #: STING
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2013
• Last updated: April 17, 2013
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2013
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: Karel Caca, Prof. Dr.
• Phone: +49714167201
• Email: karel.caca[@]kliniken-lb.de
• Is FDA regulated: No
• Health authority: Ethics comission Stuttgart, Germany:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage

Intervention

Device:
• Endoscopic hemostasis
Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (8)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH	Klinikum Augsburg, Klinikum Garmisch-Patenkirchen, Klinikum Stadt Hanau, Marienkrankenhaus Frankfurt, Universitätsklinikum Hamburg-Eppendorf, University Hospital Tuebingen, University of Zurich

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	No
Secondary	blood units transfused		30 days	No
Secondary	duration of hospital stay		30 days	No
Secondary	duration of intensive care unit stay		30 days	No
Secondary	30 d Mortality		30 days	No
Secondary	Amount of endoscopic reinterventions		7 d	No
Secondary	Necessity of surgical or angiographic therapy		7 d	No
Secondary	Complications during or after OTSC (Over The Scope Clip) placement		7 d	Yes