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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Upper Gastrointestinal Hemorrhage Device: Endoscopic hemostasis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Therapy
Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
 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
Experimental: OTSC (Over The Scope Clip)
Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
 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


Outcome Measures
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Primary Outcome Measures :
  1. Persistent bleeding or Rebleeding with 7 days [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. blood units transfused [ Time Frame: 30 days ]
  2. duration of hospital stay [ Time Frame: 30 days ]
  3. duration of intensive care unit stay [ Time Frame: 30 days ]
  4. 30 d Mortality [ Time Frame: 30 days ]
  5. Amount of endoscopic reinterventions [ Time Frame: 7 d ]
  6. Necessity of surgical or angiographic therapy [ Time Frame: 7 d ]
  7. Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 d ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836900


Contacts
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Contact: Karel Caca, Prof. Dr. +49714167201 karel.caca@kliniken-lb.de
Contact: Arthur Schmidt, Dr. +49714167201 arthur.schmidt@kliniken-lb.de

Locations
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Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany, 71640
Contact: Arthur Schmidt, Dr    +49714167201    arthur.schmidt@klinken-lb.de   
Contact: Katja Hahmann-Dolle, Dr.    +49714167201    katja.hahmann-dolle@klinken-lb.de   
Sub-Investigator: Arthur Schmidt, Dr.         
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
University Hospital Tuebingen
University Hospital Augsburg
Marienkrankenhaus Frankfurt
Klinikum Stadt Hanau
Klinikum Garmisch-Patenkirchen
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier: NCT01836900    
Other Study ID Numbers: STING
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013
Keywords provided by Kliniken Ludwigsburg-Bietigheim gGmbH:
OTSC
Upper gastrointestinal bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
 Digestive System Diseases
Hemostatics
Coagulants