Advertisement

Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial

  • Xiaoya Luo
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Ming Ji
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Shutian Zhang
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Xin Chen
    Affiliations
    Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China
    Search for articles by this author
  • Ye Zong
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Xi Zhang
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Haiyi Hu
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Xiaowen Hao
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Linlin Shao
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Can Sun
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Haiyun Shi
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Junxiong Wang
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
  • Bangmao Wang
    Affiliations
    Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University, Tianjin, China
    Search for articles by this author
  • Peng Li
    Correspondence
    Reprint requests: Peng Li, MD, Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing 100050, China.
    Affiliations
    Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Disease, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
    Search for articles by this author
Published:April 02, 2022DOI:https://doi.org/10.1016/j.gie.2022.03.024

      Background and Aims

      Disposable gastroscopes have recently been developed to eliminate the risk of infection transmission from contaminated reusable gastroscopes. We compared the performance of disposable and reusable gastroscopes in patients undergoing gastroscopy.

      Methods

      Patients requiring gastroscopy were randomized to either the disposable or reusable digital gastroscope group. The primary endpoint was the success rate of photographing customary anatomic sites, with a noninferiority margin of –8%. Secondary endpoints were technical performance factors such as gastroscope imaging quality, maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, and safety. Data were analyzed using the Newcombe-Wilson score method and Fisher exact 2-tailed t test.

      Results

      Of 110 patients, 55 were treated using disposable gastroscopes and 55 using reusable gastroscopes. The success rate for capturing images of customary anatomic sites was 100% in both groups. The average imaging quality score was significantly lower (37.02 ± 3.09 vs 39.47 ± 1.92, P < .001) and the operating time significantly longer (P < .001) in the disposable gastroscope group. No significant differences in maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, or safety were found between the 2 groups.

      Conclusions

      Given the overall safety profile and similar technical performance, disposable gastroscopes represent an alternative to reusable gastroscopes for routine examination, bedside first aid, and some certain circumstances.

      Abbreviations:

      CI (confidence interval), COVID-19 (coronavirus disease 2019)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Rauwers A.W.
        • Troelstra A.
        • Fluit A.C.
        • et al.
        Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae.
        Gastrointest Endosc. 2019; 90: 793-804
        • Bajolet O.
        • Ciocan D.
        • Vallet C.
        • et al.
        Gastroscopy-associated transmission of extended-spectrum beta-lactamase-producing Pseudomonas aeruginosa.
        J Hosp Infect. 2013; 83: 341-343
        • Ofstead C.L.
        • Hopkins K.M.
        • Buro B.L.
        • et al.
        Challenges in achieving effective high-level disinfection in endoscope reprocessing.
        Am J Infect Control. 2020; 48: 309-315
      1. U.S. Food and Drug Administration. FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection (August 29, 2019). Available at: https://www.fda.gov/news-events/press-announcements/fda-recommends-health-care-facilities-and-manufacturers-begin-transitioning-duodenoscopes-disposable. Accessed April 25, 2022.

      2. U.S. Food and Drug Administration. FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing (December 13, 2019). Available at: https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective. Accessed April 25, 2022.

        • Muthusamy V.R.
        • Bruno M.J.
        • Kozarek R.A.
        • et al.
        Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography.
        Clin Gastroenterol Hepatol. 2020; 18: 2108-2117
        • Ross A.S.
        • Bruno M.J.
        • Kozarek R.A.
        • et al.
        Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: a randomized bench-model comparison.
        Gastrointest Endosc. 2020; 91: 396-403
        • Bisschops R.
        • Areia M.
        • Coron E.
        • et al.
        Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy quality improvement initiative.
        United Eur Gastroenterol J. 2016; 4: 629-656
        • Sasaki S.
        • Nishikawa J.
        • Yanai H.
        • et al.
        Image quality of a novel light-emitting diode (LED)-illuminated colonoscope.
        Endoscopy. 2016; 48: 934-938
        • Beg S.
        • Ragunath K.
        • Wyman A.
        • et al.
        Quality standards in upper gastrointestinal endoscopy: a position statement of the British Society of Gastroenterology (BSG) and Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS).
        Gut. 2017; 66: 1886-1899
        • Early D.S.
        • Lightdale J.R.
        • Vargo J.J.
        • et al.
        • ASGE Standards of Practice Committee
        Guidelines for sedation and anesthesia in GI endoscopy.
        Gastrointest Endosc. 2018; 87: 327-337
        • Xu F.
        • Yang Y.
        • Ding Z.
        Esophagogastroduodenoscopy procedure using disposable endoscope to detect the cause of melena in a patient with COVID-19.
        Dig Endosc. 2021; 33: e1-e2
        • Van Compernolle D.
        • Veys R.
        • Elshout P.J.
        • et al.
        Reusable, single-use, or both: a cost efficiency analysis of flexible ureterorenoscopes after 983 cases.
        J Endourol. 2021; 35: 1454-1459

      Linked Article