Acute Upper Gastrointestinal HemorrhageSTINGNCT01836900
Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
A study testing Endoscopic hemostasis in people with Acute Upper Gastrointestinal Hemorrhage, run by Kliniken Ludwigsburg-Bietigheim gGmbH at 1 site in Germany.
Trial 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. 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?
- Endoscopic hemostasis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Apr 2015
- 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
- Recurrence of bleeding from gastroduodenal ulcers
Who cannot join
- Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Ludwigsburg
Ludwigsburg, 71640
Arthur Schmidt, Dr, +49714167201, arthur.schmidt@klinken-lb.de
Katja Hahmann-Dolle, Dr., +49714167201, katja.hahmann-dolle@klinken-lb.de
About this study
Official title: Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
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.
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Being tested
- Endoscopic hemostasis
- Keywords
- OTSC, Upper gastrointestinal bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic hemostasisDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution Receives: Device: Endoscopic hemostasis |
| OTSC (Over The Scope Clip) | Experimental | Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution Receives: Device: Endoscopic hemostasis |
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 d
Necessity of surgical or angiographic therapy
Measured: 7 d
Complications during or after OTSC (Over The Scope Clip) placement
Measured: 7 d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionApr 2015 (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
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Augsburg, Marienkrankenhaus Frankfurt, Klinikum Stadt Hanau, Klinikum Garmisch-Patenkirchen, University of Zurich, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836900
- Sponsor's protocol ID
- STING
- Acronym
- STING
- Status last verified
- Apr 2013
- First submitted
- 15 Apr 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29803838
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
- ClinicalTrials.gov ID
- NCT01836900
- Acronym / sponsor ID
- STING / STING
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Keywords
- OTSC, Upper gastrointestinal bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbHUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, University Hospital Augsburg, Marienkrankenhaus Frankfurt, Klinikum Stadt Hanau, Klinikum Garmisch-Patenkirchen, University of Zurich, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 22 Apr 2013 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Device: Endoscopic hemostasisEndoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution |
| OTSC (Over The Scope Clip) | Experimental | Device: Endoscopic hemostasisEndoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recurrence of bleeding from gastroduodenal ulcers
Key exclusion criteria (1 listed)
- Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
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 |
|---|---|---|
| Endoscopic hemostasisHemostasis 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 | Device | OTSC (Over The Scope Clip), 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 d
Necessity of surgical or angiographic therapy
Time frame: 7 d
Complications during or after OTSC (Over The Scope Clip) placement
Time frame: 7 d
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Derived from this study: PubMed 29803838Schmidt 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.
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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 Endoscopic hemostasis 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 1 inclusion and 1 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 22 Apr 2013. 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. Dr. (+49714167201, 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 NCT01836900, 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 22 Apr 2013.