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Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2) (STING2)

Primary Purpose

Acute Upper Gastrointestinal Hemorrhage

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
OTSC
Endoscopic Standard therapy (combining two methods)
Sponsored by
Kliniken Ludwigsburg-Bietigheim gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Gastrointestinal Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • upper GI-bleeding (non-variceal) with high risk of recurrency
  • 18 years and older

Exclusion Criteria:

  • variceal-bleeding
  • under 18 years
  • pregnancy or nursing period
  • malignancy
  • need for surgical treatment (for example perforation with peritonitis)

Sites / Locations

  • Klinikum LudwigsburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OTSC

Standard therapy

Arm Description

Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.

Endoscopic standard therapy (two techniques e.g. clip and injection)

Outcomes

Primary Outcome Measures

Persistent bleeding or Rebleeding with 7 days

Secondary Outcome Measures

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

Full Information

First Posted
October 24, 2017
Last Updated
October 31, 2017
Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
Collaborators
University Hospital Freiburg, University Hospital Ulm, University Hospital Goettingen, Evangelisches Krankenhaus Düsseldorf, University Hospital, Essen, University of Leipzig, University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03331224
Brief Title
Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
Acronym
STING2
Official Title
Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kliniken Ludwigsburg-Bietigheim gGmbH
Collaborators
University Hospital Freiburg, University Hospital Ulm, University Hospital Goettingen, Evangelisches Krankenhaus Düsseldorf, University Hospital, Essen, University of Leipzig, University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and 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
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score > 6) and randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. 100 Patients are planned. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTSC
Arm Type
Experimental
Arm Description
Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Endoscopic standard therapy (two techniques e.g. clip and injection)
Intervention Type
Device
Intervention Name(s)
OTSC
Intervention Description
OTSC placement
Intervention Type
Device
Intervention Name(s)
Endoscopic Standard therapy (combining two methods)
Intervention Description
endoscopic standard therapy (two methods, e.g. clip and injection)
Primary Outcome Measure Information:
Title
Persistent bleeding or Rebleeding with 7 days
Time Frame
7 days
Secondary Outcome Measure Information:
Title
blood units transfused
Time Frame
30 days
Title
duration of hospital stay
Time Frame
30 days
Title
duration of intensive care unit stay
Time Frame
30 days
Title
30 d Mortality
Time Frame
30 days
Title
Amount of endoscopic reinterventions
Time Frame
7 days
Title
Necessity of surgical or angiographic therapy
Time Frame
7 days
Title
Complications during or after OTSC (Over The Scope Clip) placement
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: upper GI-bleeding (non-variceal) with high risk of recurrency 18 years and older Exclusion Criteria: variceal-bleeding under 18 years pregnancy or nursing period malignancy need for surgical treatment (for example perforation with peritonitis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karel Caca, Prof
Phone
004971419967201
Email
karel.caca@kliniken-lb.de
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Meier
Phone
004971419967201
Email
benjamin.meier@kliniken-lb.de
First Name & Middle Initial & Last Name & Degree
Karel Caca
Phone
004971419967201
Email
karel.caca@kliniken-lb.de
First Name & Middle Initial & Last Name & Degree
Karel Caca, Prof.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35321938
Citation
Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, Wedi E, Zachaus M, Pickartz T, Kullmer A, Schmidt A, Caca K. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2). Gut. 2022 Jul;71(7):1251-1258. doi: 10.1136/gutjnl-2021-325300. Epub 2022 Mar 23.
Results Reference
derived

Learn more about this trial

Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)

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