Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
STING2
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedNovember 6, 2017
October 1, 2017
2 years
October 24, 2017
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Persistent bleeding or Rebleeding with 7 days
7 days
Secondary Outcomes (7)
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 days
- +2 more secondary outcomes
Study Arms (2)
OTSC
EXPERIMENTALInitial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
Standard therapy
ACTIVE COMPARATOREndoscopic standard therapy (two techniques e.g. clip and injection)
Interventions
endoscopic standard therapy (two methods, e.g. clip and injection)
Eligibility Criteria
You may qualify if:
- upper GI-bleeding (non-variceal) with high risk of recurrency
- years and older
You may not qualify if:
- variceal-bleeding
- under 18 years
- pregnancy or nursing period
- malignancy
- need for surgical treatment (for example perforation with peritonitis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kliniken Ludwigsburg-Bietigheim gGmbHlead
- University Hospital Freiburgcollaborator
- University Hospital Ulmcollaborator
- University Hospital Goettingencollaborator
- Evangelisches Krankenhaus Düsseldorfcollaborator
- University Hospital, Essencollaborator
- University of Leipzigcollaborator
- University Hospital Tuebingencollaborator
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, Germany
Related Publications (1)
Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, Wedi E, Zachaus M, Pickartz T, Kullmer A, Schmidt A, Caca K. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2). Gut. 2022 Jul;71(7):1251-1258. doi: 10.1136/gutjnl-2021-325300. Epub 2022 Mar 23.
PMID: 35321938DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
November 6, 2017
Study Start
September 1, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
November 6, 2017
Record last verified: 2017-10