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

NCT01836900 — Not applicable, Unknown, 64 participants, Kliniken Ludwigsburg-Bietigheim gGmbH

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

Registry	NCT01836900, acronym STING
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	64 (Estimated)
Sponsor	Kliniken Ludwigsburg-Bietigheim gGmbH (Other); collaborators: University Hospital Tuebingen, University Hospital Augsburg, Marienkrankenhaus Frankfurt, Klinikum Stadt Hanau, Klinikum Garmisch-Patenkirchen, University of Zurich, Universitätsklinikum Hamburg-Eppendorf
Conditions	Acute Upper Gastrointestinal Hemorrhage
Interventions	Endoscopic hemostasis (Device)
Dates	start 2013-03-01, primary completion 2015-03-01 (estimated), completion 2015-04-01 (estimated), first posted 2013-04-22, last updated 2013-04-22
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard Therapy	Active comparator	Device: Endoscopic hemostasis	Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
OTSC (Over The Scope Clip)	Experimental	Device: Endoscopic hemostasis	Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution

Endoscopic hemostasis (Device): 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

+Outcome measures

Primary outcomes

Persistent bleeding or Rebleeding with 7 days [7 days]

Secondary outcomes

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 d]
Necessity of surgical or angiographic therapy [7 d]
Complications during or after OTSC (Over The Scope Clip) placement [7 d]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Klinikum Ludwigsburg	Ludwigsburg	Germany	Recruiting

+Publications

Results publication: Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24. PMID 29803838