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Status unknownNCT01836900STINGUpdated Apr 22, 2013

Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy

An interventional study of Endoscopic hemostasis in Acute Upper Gastrointestinal Hemorrhage, sponsored by Kliniken Ludwigsburg-Bietigheim gGmbH. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-22.

Sponsored by Kliniken Ludwigsburg-Bietigheim gGmbH · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Acute Upper Gastrointestinal Hemorrhage

Keywords

  • OTSC
  • Upper gastrointestinal bleeding
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In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's planned enrollment of 64 is below the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Recurrence of bleeding from gastroduodenal ulcers

Exclusion criteria

Exclusion Criteria:

  • Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Active comparator
    Standard Therapy

    Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution

    Device: Endoscopic hemostasis

  • Experimental
    OTSC (Over The Scope Clip)

    Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution

    Device: Endoscopic hemostasis

Interventions

  • DeviceEndoscopic hemostasis

    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

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What researchers measure

Primary outcomes

  1. Persistent bleeding or Rebleeding with 7 days

    Time frame: 7 days

Secondary outcomes

  1. blood units transfused

    Time frame: 30 days

  2. duration of hospital stay

    Time frame: 30 days

  3. duration of intensive care unit stay

    Time frame: 30 days

  4. 30 d Mortality

    Time frame: 30 days

  5. Amount of endoscopic reinterventions

    Time frame: 7 d

  6. Necessity of surgical or angiographic therapy

    Time frame: 7 d

  7. Complications during or after OTSC (Over The Scope Clip) placement

    Time frame: 7 d

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Study locations

1 of 1 sites recruiting
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01836900
Lead sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
Collaborators
University Hospital Tuebingen, University Hospital Augsburg, Marienkrankenhaus Frankfurt, Klinikum Stadt Hanau, Klinikum Garmisch-Patenkirchen, University of Zurich, Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Apr 22, 2013
Start date
Mar 2013
Primary completion
Mar 2015 (estimated)
Completion
Apr 2015 (estimated)
Last update
Apr 22, 2013

Study contacts

Karel Caca, Prof. Dr.
Contact
karel.caca@kliniken-lb.de
+49714167201
Arthur Schmidt, Dr.
Contact
arthur.schmidt@kliniken-lb.de
+49714167201

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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