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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor:
Collaborators:
University Hospital Tuebingen
Klinikum Augsburg
Marienkrankenhaus Frankfurt
Klinikum Hanau
Klinikum Garmisch-Patenkirchen
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier:
NCT01836900
First received: April 15, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Acute Upper Gastrointestinal Hemorrhage
Device: Endoscopic hemostasis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy

Resource links provided by NLM:


Further study details as provided by Kliniken Ludwigsburg-Bietigheim gGmbH:

Primary Outcome Measures:
  • Persistent bleeding or Rebleeding with 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood units transfused [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • duration of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • duration of intensive care unit stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 30 d Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Amount of endoscopic reinterventions [ Time Frame: 7 d ] [ Designated as safety issue: No ]
  • Necessity of surgical or angiographic therapy [ Time Frame: 7 d ] [ Designated as safety issue: No ]
  • Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836900

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

Locations
Germany
Klinikum Ludwigsburg Recruiting
Ludwigsburg, Germany, 71640
Contact: Arthur Schmidt, Dr    +49714167201    arthur.schmidt@klinken-lb.de   
Contact: Katja Hahmann-Dolle, Dr.    +49714167201    katja.hahmann-dolle@klinken-lb.de   
Sub-Investigator: Arthur Schmidt, Dr.         
Sponsors and Collaborators
Kliniken Ludwigsburg-Bietigheim gGmbH
University Hospital Tuebingen
Klinikum Augsburg
Marienkrankenhaus Frankfurt
Klinikum Hanau
Klinikum Garmisch-Patenkirchen
University of Zurich
Universitätsklinikum Hamburg-Eppendorf
  More Information

No publications provided

Responsible Party: Kliniken Ludwigsburg-Bietigheim gGmbH
ClinicalTrials.gov Identifier: NCT01836900     History of Changes
Other Study ID Numbers: STING
Study First Received: April 15, 2013
Last Updated: April 17, 2013
Health Authority: Ethics comission Stuttgart, Germany:

Keywords provided by Kliniken Ludwigsburg-Bietigheim gGmbH:
OTSC
Upper gastrointestinal bleeding

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Hemostatics
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014