Clinical trial NCT03331224: Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
Official title: Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Upper Gastrointestinal Hemorrhage
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
name: University Hospital Ulm
name: University Hospital Goettingen
name: Evangelisches Krankenhaus Düsseldorf
name: University Hospital, Essen
name: University of Leipzig
name: University Hospital Tuebingen
First posted: 2017-11-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Persistent bleeding or Rebleeding with 7 days
timeFrame: 7 days
Secondary outcomes:
measure: blood units transfused
timeFrame: 30 days
measure: duration of hospital stay
timeFrame: 30 days
measure: duration of intensive care unit stay
timeFrame: 30 days
measure: 30 d Mortality
timeFrame: 30 days
measure: Amount of endoscopic reinterventions
timeFrame: 7 days
measure: Necessity of surgical or angiographic therapy
timeFrame: 7 days
measure: Complications during or after OTSC (Over The Scope Clip) placement
timeFrame: 7 days
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
Study officials:
References:
citation: 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.