Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
STING
1 other identifier
interventional
64
1 country
1
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.
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 Mar 2013
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 15, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 22, 2013
April 1, 2013
2 years
April 15, 2013
April 17, 2013
Conditions
Keywords
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 d
- +2 more secondary outcomes
Study Arms (2)
Standard Therapy
ACTIVE COMPARATOREndoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
OTSC (Over The Scope Clip)
EXPERIMENTALEndoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
Interventions
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
Eligibility Criteria
You may qualify if:
- Recurrence of bleeding from gastroduodenal ulcers
You may not qualify if:
- Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kliniken Ludwigsburg-Bietigheim gGmbHlead
- University Hospital Tuebingencollaborator
- University Hospital Augsburgcollaborator
- Marienkrankenhaus Frankfurtcollaborator
- Klinikum Stadt Hanaucollaborator
- Klinikum Garmisch-Patenkirchencollaborator
- University of Zurichcollaborator
- Universitätsklinikum Hamburg-Eppendorfcollaborator
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Related Publications (1)
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: 29803838DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2013
First Posted
April 22, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
April 22, 2013
Record last verified: 2013-04