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

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ClinicalTrials.gov Identifier: NCT01836900
Recruitment Status : Unknown
Verified April 2013 by Kliniken Ludwigsburg-Bietigheim gGmbH.
Recruitment status was:  Recruiting
First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
University Hospital Tuebingen
University Hospital Augsburg
Marienkrankenhaus Frankfurt
Klinikum Stadt Hanau
Klinikum Garmisch-Patenkirchen
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Kliniken Ludwigsburg-Bietigheim gGmbH

Tracking Information
First Submitted Date  ICMJE April 15, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)		 Persistent bleeding or Rebleeding with 7 days [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • blood units transfused [ Time Frame: 30 days ]
  • duration of hospital stay [ Time Frame: 30 days ]
  • duration of intensive care unit stay [ Time Frame: 30 days ]
  • 30 d Mortality [ Time Frame: 30 days ]
  • Amount of endoscopic reinterventions [ Time Frame: 7 d ]
  • Necessity of surgical or angiographic therapy [ Time Frame: 7 d ]
  • Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 d ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
Official Title  ICMJE Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Upper Gastrointestinal Hemorrhage
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Standard Therapy
    Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
    Intervention: Device: Endoscopic hemostasis
  • Experimental: OTSC (Over The Scope Clip)
    Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
    Intervention: Device: Endoscopic hemostasis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)		 64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01836900
Other Study ID Numbers  ICMJE STING
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Kliniken Ludwigsburg-Bietigheim gGmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kliniken Ludwigsburg-Bietigheim gGmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University Hospital Tuebingen
  • University Hospital Augsburg
  • Marienkrankenhaus Frankfurt
  • Klinikum Stadt Hanau
  • Klinikum Garmisch-Patenkirchen
  • University of Zurich
  • Universitätsklinikum Hamburg-Eppendorf
Investigators  ICMJE Not Provided
PRS Account Kliniken Ludwigsburg-Bietigheim gGmbH
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP