Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial

医学 食管胃十二指肠镜检查 背景(考古学) 前瞻性队列研究 随机对照试验 上消化道出血 胃肠道出血 胃肠道 普通外科 临床试验 内科学 外科 内镜治疗 内窥镜检查 临床终点 急诊科 内镜治疗
作者
Christoph Römmele,Mousa Ayoub,Markus W. Scheppach,Anna Muzalyova,Julia Wanzl,Vidan Tadic,Georg Braun,Tobias Weber,D Röser,Sandra Nagl,Helmut Messmann,Alanna Ebigbo
出处
期刊:Endoscopy [Thieme Medical Publishers (Germany)]
卷期号:58 (05): 481-490 被引量:3
标识
DOI:10.1055/a-2735-1114
摘要

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%; 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. 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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