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

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ClinicalTrials.gov Identifier: NCT03331224
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
University Hospital Freiburg
University Hospital Ulm
University Hospital Goettingen
Evangelisches Krankenhaus Düsseldorf
University Hospital, Essen
University of Leipzig
University Hospital Tuebingen
Information provided by (Responsible Party):
Kliniken Ludwigsburg-Bietigheim gGmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Upper Gastrointestinal Hemorrhage Device: OTSC Device: Endoscopic Standard therapy (combining two methods) Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTSC
Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
Device: OTSC
OTSC placement

Active Comparator: Standard therapy
Endoscopic standard therapy (two techniques e.g. clip and injection)
Device: Endoscopic Standard therapy (combining two methods)
endoscopic standard therapy (two methods, e.g. clip and injection)




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 days ]
  6. Necessity of surgical or angiographic therapy [ Time Frame: 7 days ]
  7. Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 days ]


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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:

  • 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)

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): NCT03331224


Contacts
Contact: Karel Caca, Prof 004971419967201 karel.caca@kliniken-lb.de

Locations
Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany
Contact: Benjamin Meier    004971419967201    benjamin.meier@kliniken-lb.de   
Contact: Karel Caca    004971419967201    karel.caca@kliniken-lb.de   
Principal Investigator: Karel Caca, Prof.         
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
University Hospital Freiburg
University Hospital Ulm
University Hospital Goettingen
Evangelisches Krankenhaus Düsseldorf
University Hospital, Essen
University of Leipzig
University Hospital Tuebingen

Responsible Party: Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier: NCT03331224     History of Changes
Other Study ID Numbers: STING2
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases