Acute Upper Gastrointestinal HemorrhageSTING2NCT03331224
Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
A study testing OTSC and Endoscopic Standard therapy (combining two methods) in people with Acute Upper Gastrointestinal Hemorrhage, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Hemorrhage
- What is being tested?
- OTSC and Endoscopic Standard therapy (combining two methods)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- upper GI-bleeding (non-variceal) with high risk of recurrency
- 18 years and older
Who cannot join
- variceal-bleeding
- under 18 years
- pregnancy or nursing period
- malignancy
- need for surgical treatment (for example perforation with peritonitis)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg
Benjamin Meier, 004971419967201, benjamin.meier@kliniken-lb.de
Karel Caca, 004971419967201, karel.caca@kliniken-lb.de
About this study
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.
Read the 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.
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Being tested
- OTSC, Endoscopic Standard therapy (combining two methods)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTSCDevice
OTSC placement
Endoscopic Standard therapy (combining two methods)Device
endoscopic standard therapy (two methods, e.g. clip and injection)
| Study group | Role | What they receive |
|---|---|---|
| OTSC | Experimental | Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency. Receives: Device: OTSC |
| Standard therapy | Active comparator | Endoscopic standard therapy (two techniques e.g. clip and injection) Receives: Device: Endoscopic Standard therapy (combining two methods) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent bleeding or Rebleeding with 7 days
Measured: 7 days
Secondary outcomes (7)
blood units transfused
Measured: 30 days
duration of hospital stay
Measured: 30 days
duration of intensive care unit stay
Measured: 30 days
30 d Mortality
Measured: 30 days
Amount of endoscopic reinterventions
Measured: 7 days
Necessity of surgical or angiographic therapy
Measured: 7 days
Complications during or after OTSC (Over The Scope Clip) placement
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg, University Hospital Ulm, University Hospital Goettingen, Evangelisches Krankenhaus Düsseldorf, University Hospital, Essen, University of Leipzig, University Hospital Tuebingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03331224
- Sponsor's protocol ID
- STING2
- Acronym
- STING2
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35321938
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
- ClinicalTrials.gov ID
- NCT03331224
- Acronym / sponsor ID
- STING2 / STING2
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Collaborators
- University Hospital Freiburg, University Hospital Ulm, University Hospital Goettingen, Evangelisches Krankenhaus Düsseldorf, University Hospital, Essen, University of Leipzig, University Hospital Tuebingen
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTSC | Experimental | Device: OTSCInitial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency. |
| Standard therapy | Active comparator | Device: Endoscopic Standard therapy (combining two methods)Endoscopic standard therapy (two techniques e.g. clip and injection) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- upper GI-bleeding (non-variceal) with high risk of recurrency
- 18 years and older
Key exclusion criteria (5 listed)
- variceal-bleeding
- under 18 years
- pregnancy or nursing period
- malignancy
- need for surgical treatment (for example perforation with peritonitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTSCOTSC placement | Device | OTSC |
| Endoscopic Standard therapy (combining two methods)endoscopic standard therapy (two methods, e.g. clip and injection) | Device | Standard therapy |
Primary outcome
Persistent bleeding or Rebleeding with 7 days
Time frame: 7 days
7 secondary outcomes
blood units transfused
Time frame: 30 days
duration of hospital stay
Time frame: 30 days
duration of intensive care unit stay
Time frame: 30 days
30 d Mortality
Time frame: 30 days
Amount of endoscopic reinterventions
Time frame: 7 days
Necessity of surgical or angiographic therapy
Time frame: 7 days
Complications during or after OTSC (Over The Scope Clip) placement
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 35321938Meier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTSC and Endoscopic Standard therapy (combining two methods) in people with Acute Upper Gastrointestinal Hemorrhage, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karel Caca, Prof (004971419967201, karel.caca@kliniken-lb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent bleeding or Rebleeding with 7 days (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03331224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.