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DOI: 10.1055/a-2735-1114
Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial
Authors
Supported by: ambu GmbH
Clinical Trial:
Registration number (trial ID): NCT06192355, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: prospective single-centre randomised controlled unblinded non-inferiority trial
Abstract
Background
Recently, several single-use endoscopes have been developed; however, their clinical performance remains unclear. This trial aimed to compare the performance of single-use gastroscopes (SUGs) with that of reusable gastroscopes (RUGs), 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 to undergo EGD with either an SUG or an RUG. The primary outcome was complete assessment of the upper gastrointestinal (UGI) tract for the presence of a bleeding site.
Results
148 patients were included. A complete assessment of the UGI tract was achieved in 72/74 patients with the SUG and in 71/74 patients with the RUG (97.3% vs. 95.9%; P < 0.001); however, the bleeding site was identified significantly more frequently in the RUG group (83.8% vs. 68.9%; P = 0.03). The need for a therapeutic intervention did not differ between the groups (55.4% vs. 50.0%; P = 0.51). Five crossovers to an RUG occurred, largely owing to better visualization and user experience.
Conclusions
SUGs are noninferior to RUGs in the complete assessment of the UGI tract in patients with signs of UGIB; however, a significantly higher rate of bleeding site identification, superior visualization quality, greater acceptance by endoscopists, and a trend toward more effective therapeutic performance was achieved with RUGs.
Publication History
Received: 26 May 2025
Accepted after revision: 29 October 2025
Accepted Manuscript online:
29 October 2025
Article published online:
17 December 2025
© 2025. Thieme. All rights reserved.
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