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

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).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.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%; <i>P</i> < 0.001); however, the bleeding site was identified significantly more frequently in the RUG group (83.8% vs. 68.9%; <i>P</i> = 0.03). The need for a therapeutic intervention did not differ between the groups (55.4% vs. 50.0%; <i>P</i> = 0.51). Five crossovers to an RUG occurred, largely owing to better visualization and user experience.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.

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Publication Details

Journal
Endoscopy
Published
2025-10-29
DOI
https://doi.org/10.1055/a-2735-1114
Primary Topic
Medical Device Sterilization and Disinfection
Type
article
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article

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

Christoph Römmele, Vidan Tadic, Anna Muzalyova, Julia Wanzl et al.
Endoscopy
Medical Device Sterilization and Disinfection
article

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

Christoph Römmele, Vidan Tadic, Anna Muzalyova, Julia Wanzl, Tobias Weber, Markus W. Scheppach, Alanna Ebigbo, Helmut Messmann, Sandra Nagl, Mousa Ayoub, Georg Braun, D Röser
article en

Abstract

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).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.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%; <i>P</i> < 0.001); however, the bleeding site was identified significantly more frequently in the RUG group (83.8% vs. 68.9%; <i>P</i> = 0.03). The need for a therapeutic intervention did not differ between the groups (55.4% vs. 50.0%; <i>P</i> = 0.51). Five crossovers to an RUG occurred, largely owing to better visualization and user experience.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.

Endoscopy
University Hospital Augsburg (DE), St. Josef-Hospital (DE)
Openalex Percentile: Top 71%
Medical Device Sterilization and Disinfection
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