Efficacy and safety of over-the-scope clips® com-pared to through-the-scope clips for initial bleeding control in non-variceal upper gastrointestinal bleeding: a multicenter randomized clinical trial

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Flávia Lopes
Maria Simon
https://orcid.org/
Daniela Masoli
Carla Mori
https://orcid.org/
Rachel Lima
https://orcid.org/0000-0001-9123-3413
Erlon Abreu-Silva
Shajahan Idayathulla
https://orcid.org/
Stefano Monfrini
https://orcid.org/
Nicolás Cáceres
https://orcid.org/
Muhammad Umair Khan

Abstract

Introduction: Non-variceal upper gastrointestinal bleeding still poses a serious health problem due to high rebleeding rates, despite multiple treatment options. The relatively new over-the-scope clips® technique may be an effective alternative used in clinical practice and showed promising efficacy in predominantly observational studies. However, superiority over another mechanical technique as first-line therapy has not been established yet regarding initial hemostasis and recurring bleeding.


Methods: The study will be a phase II, randomized, controlled, blinded, multicenter, parallel-group, superiority trial with a 1:1 allocation ratio. Adult patients with Ia-IIb Forrest classified ulcers will be randomized to either over-the-scope clips ® or through-the-scope clips. The primary outcome will be successful initial hemostasis and will be assessed by the endoscopist immediately after the procedure. Secondary outcomes will be rebleeding rate assessed by second-look endoscopy in case of substantial bleeding indicators, number of clips used, and mortality rate within 30 days. Further, the occurrence of adverse device effects will be assessed. Patient follow-up will occur periodically for a 3-month time frame.


Discussion: By comparing two mechanical techniques for the treatment of common ulcers, our study will provide valuable grounds to deduce recommendations for first-line definite treatment and prevention of recurrent bleeding episodes.


Trial registration: The trial will be registered at ClinicalTrials.gov (https://clinicaltrials.gov/).


Keywords: upper gastrointestinal bleeding, hemostasis, bleeding control, OTSC, clinical trial

Article Details

How to Cite
Lopes, F., S. Simon, M. ., Masoli, D., Francine Arico Mori, C., Pereira Lima, R. ., Oliveira de Abreu-Silva, E. ., Idayathulla, S., Monfrini, S., Cuba Cáceres, N., & Umair Khan, M. . (2022). Efficacy and safety of over-the-scope clips® com-pared to through-the-scope clips for initial bleeding control in non-variceal upper gastrointestinal bleeding: a multicenter randomized clinical trial. Principles and Practice of Clinical Research, 8(3), 1–9. https://doi.org/10.21801/ppcrj.2022.83.3
Section
Clinical Research Design