Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit

Обзор

The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity. The main question the study aims to answer is: \- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit? Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings. Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable gastroscope.

Вмешательства

• Устройство Ambu aScope Gastro
  CE-marked single-use gastroscopes from Ambu are used in the single-use group.
• Устройство Reusable diagnostic gastroscopes (Olympus)
  Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

Первичные конечные точки

• Endoscopist-rated composite usability score [Срок оценки: Procedure day (immediately after completion of the procedure)]
• Cost per gastroscopy during the single-use period compared with the reusable period [Срок оценки: During the gastroscopy procedure and completion of all procedure-related activities (same day).]

Вторичные конечные точки (8)

• Technical success of single-use gastroscopes vs reusable gastroscopes [Срок оценки: During the procedure]
• Cross-over rate [Срок оценки: During the procedure]
• Frequency of predefined endoscopic findings [Срок оценки: During the procedure]
• Complications [Срок оценки: 24 hours and 72 hours follow-up after the procedure]
• 30-day mortality [Срок оценки: 30 days after the procedure]
• Duration of procedure [Срок оценки: During the procedure]
• Technical success rate of therapeutic endoscopic procedures [Срок оценки: During the procedure]
• Diagnostic adequacy rate of endoscopic biopsies [Срок оценки: After completion of the pathology examination (up to 2 months after the procedure)]

Критерии участия

Критерии включения

• Elective or subacute gastroscopy in the endoscopy unit
• Age ≥ 18 years

Критерии исключения

• Surveillance gastroscopy for Barrett's esophagus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Дания · 1 центр

• Zealand University Hospital — Køge

Публикации

• Rommele C, Ayoub M, Scheppach MW, Muzalyova A, Wanzl J, Tadic V, Braun G, Weber T, Roser D, Nagl S, Messmann H, Ebigbo A. Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial. Endoscopy. 2026 May;58(5):481-490. doi: 10.1055/a-2735-1114. Epub 2025 Oct 29. PMID 41161323
• Weusten BLAM, Bisschops R, Dinis-Ribeiro M, di Pietro M, Pech O, Spaander MCW, Baldaque-Silva F, Barret M, Coron E, Fernandez-Esparrach G, Fitzgerald RC, Jansen M, Jovani M, Marques-de-Sa I, Rattan A, Tan WK, Verheij EPD, Zellenrath PA, Triantafyllou K, Pouw RE. Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2023 Dec;55(12 PMID 37813356
• Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17. PMID 35718068
• Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available. PMID 30772837
• Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9. PMID 35262904
• Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar. PMID 38504744
• Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30. PMID 32891225
• Rommele C, Ayoub M, Wanzl J, Tadic V, Braun G, Weber T, Scheppach MW, Roser D, Matic K, Nagl S, Messmann H, Ebigbo A. Clinical evaluation of a novel single-use therapeutic gastroscope: a pilot feasibility study. Endoscopy. 2025 Apr;57(4):339-344. doi: 10.1055/a-2436-7933. Epub 2024 Oct 8. PMID 39379048

Идентификаторы

NCT: NCT07727226 · SUSUES_endoscopyunit

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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