Single-Use versus Reusable Gastroscopes for the initial Assessment of patients with Upper Gastrointestinal Bleeding: A Prospective Randomised Non-Inferiority Trial

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Aims Recently, several single-use endoscopes have been developed for different applications. However, clinical performance in comparison with reusable scopes remains unclear. This prospective randomized controlled clinical trial aims to compare the performance of a single-use gastroscope (SUG) with that of reusable gastroscopes (RUG), in the context of emergency esophagogastroduodenoscopy (EGD) for suspected upper gastrointestinal bleeding (UGIB). Methods Patients with suspected UGIB requiring EGD between March 2023 and April 2024 were randomized into two groups, one of which received EGD with a SUG, the other with a RUG. The primary outcome was the complete assessment of the upper gastrointestinal tract (GIT) for the presence of a bleeding site defined as visualization of all relevant anatomical landmarks. Secondary outcomes included the identification of a bleeding site, successful endoscopic hemostasis and user satisfaction. A follow up on clinical outcomes was performed both during the inpatient stay and, in the case of discharge from the hospital, via telephone on day 30 after index endoscopy. Results 148 patients were included between 03/2023 and 04/2024. The primary outcome was achieved in 72 of 74 patients with the SUG and in 71 of 74 patients with the RUG (97.3% vs. 95.9%; p=0.649). The bleeding site was identified significantly more frequently in the reusable group (83.8% vs. 68.9%, p=0.033), although the need for intervention did not differ between the two groups (55.4% vs. 50.0%, p=0.510). Successful hemostasis was achieved in 32 of 35 (91.4%) cases with the SUG and in 39 of 40 (97.5%) with the RUG (p=0.249). Five crossovers to a RUG occurred. In the follow-up, no significant differences were found regarding mortality, length of hospital stay, or the need for blood transfusions. Conclusions SUG are non-inferior to RUG in the complete assessment of the upper GIT in patients with signs of UGIB as perceived by the endoscopist. However, RUG identified the bleeding site significantly more often than SUG. Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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