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

NCT ID: NCT01836900

Last Updated: 2013-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Upper Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Therapy

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

Group Type ACTIVE_COMPARATOR

Endoscopic hemostasis

Intervention Type DEVICE

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

OTSC (Over The Scope Clip)

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

Group Type EXPERIMENTAL

Endoscopic hemostasis

Intervention Type DEVICE

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

Interventions

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Endoscopic 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Recurrence of bleeding from gastroduodenal ulcers

Exclusion Criteria

* Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

University Hospital Augsburg

OTHER

Sponsor Role collaborator

Marienkrankenhaus Frankfurt

OTHER

Sponsor Role collaborator

Klinikum Stadt Hanau

OTHER

Sponsor Role collaborator

Klinikum Garmisch-Patenkirchen

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

Kliniken Ludwigsburg-Bietigheim gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Ludwigsburg

Ludwigsburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Karel Caca, Prof. Dr.

Role: CONTACT

+49714167201

Arthur Schmidt, Dr.

Role: CONTACT

+49714167201

Facility Contacts

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Arthur Schmidt, Dr

Role: primary

+49714167201

Katja Hahmann-Dolle, Dr.

Role: backup

+49714167201

References

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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.

Reference Type DERIVED
PMID: 29803838 (View on PubMed)

Other Identifiers

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STING

Identifier Type: -

Identifier Source: org_study_id

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