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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03331224

Acronym

STING2

Enrollment

120

Registered

2017-11-06

Start date

2017-09-01

Completion date

2019-09-01

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Upper Gastrointestinal Hemorrhage

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.

Interventions

DEVICEOTSC

OTSC placement

DEVICEEndoscopic Standard therapy (combining two methods)

endoscopic standard therapy (two methods, e.g. clip and injection)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Persistent bleeding or Rebleeding with 7 days	7 days

Secondary

Measure	Time frame
duration of hospital stay	30 days
duration of intensive care unit stay	30 days
30 d Mortality	30 days
blood units transfused	30 days
Necessity of surgical or angiographic therapy	7 days
Complications during or after OTSC (Over The Scope Clip) placement	7 days
Amount of endoscopic reinterventions	7 days

Countries

Germany

Contacts

Primary ContactKarel Caca, Prof

karel.caca@kliniken-lb.de004971419967201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026