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

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: Acute Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Device: Endoscopic hemostasis

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karel Caca, Prof. Dr.; Phone Number: +49714167201; Email: karel.caca@kliniken-lb.de
• Study Contact Backup: Name: Arthur Schmidt, Dr.; Phone Number: +49714167201; Email: arthur.schmidt@kliniken-lb.de

Study Locations

• Germany
  • Ludwigsburg, Germany, 71640
    • Recruiting
    • Klinikum Ludwigsburg
    • Contact: Arthur Schmidt, Dr; Phone Number: +49714167201; Email: arthur.schmidt@klinken-lb.de
    • Contact: Katja Hahmann-Dolle, Dr.; Phone Number: +49714167201; Email: katja.hahmann-dolle@klinken-lb.de
    • Sub-Investigator: Arthur Schmidt, Dr.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: OTSC; Upper gastrointestinal bleeding
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: STING