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

April 17, 2013 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Therapy
Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
Device: 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
EXPERIMENTAL: OTSC (Over The Scope Clip)
Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistent bleeding or Rebleeding with 7 days
Time Frame: 7 days
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Collaborators

University of Zurich
University Hospital Tuebingen
Klinikum Garmisch-Patenkirchen
Universitätsklinikum Hamburg-Eppendorf
University Hospital Augsburg
Klinikum Stadt Hanau
Marienkrankenhaus Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

April 1, 2015

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (ESTIMATE)

April 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STING

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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