Back to results

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

Primary Purpose

Acute Upper Gastrointestinal Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Endoscopic hemostasis

About this trial

This is an interventional treatment trial for Acute Upper Gastrointestinal Hemorrhage focused on measuring OTSC, Upper gastrointestinal bleeding

Eligibility Criteria

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

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

Sites / Locations

Klinikum LudwigsburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

OTSC (Over The Scope Clip)

Arm Description

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

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

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

NCT ID

NCT01836900

First Posted

April 15, 2013

Last Updated

April 17, 2013

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

1. Study Identification

Unique Protocol Identification Number

NCT01836900

Brief Title

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

Acronym

STING

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Unknown status

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Upper Gastrointestinal Hemorrhage

Keywords

OTSC, Upper gastrointestinal bleeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Therapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

OTSC (Over The Scope Clip)

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Endoscopic hemostasis

Intervention Description

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

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 d

Title

Necessity of surgical or angiographic therapy

Time Frame

7 d

Title

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

Time Frame

7 d

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karel Caca, Prof. Dr.

Phone

+49714167201

karel.caca@kliniken-lb.de

First Name & Middle Initial & Last Name or Official Title & Degree

Arthur Schmidt, Dr.

Phone

+49714167201

arthur.schmidt@kliniken-lb.de

Facility Information:

Facility Name

Klinikum Ludwigsburg

City

Ludwigsburg

ZIP/Postal Code

71640

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arthur Schmidt, Dr

Phone

+49714167201

arthur.schmidt@klinken-lb.de

First Name & Middle Initial & Last Name & Degree

Katja Hahmann-Dolle, Dr.

Phone

+49714167201

katja.hahmann-dolle@klinken-lb.de

First Name & Middle Initial & Last Name & Degree

Arthur Schmidt, Dr.

12. IPD Sharing Statement

Citations:

PubMed Identifier

29803838

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs