Introduction
In recent years, there have been reports about the risk of infection with multidrug-resistant bacteria via duodenoscopes1, as well as the outbreak of COVID-19, which has brought attention to endoscope-mediated infections. In response, disposable endoscopes have been developed and marketed worldwide. While there have been several reports on the feasibility of disposable endoscopes for screening or emergency examinations2,3, there are no reports on the feasibility of Endoscopic Submucosal Dissection (ESD), which requires a variety of operations with different devices.
Aims & Methods
The aim of this study was to compare the performance of disposable and reusable endoscopes in using the ESD training model (G-master, KOTOBUKI Medical), which can simulate various parts of the stomach.
ESD was performed on pseudo lesions (size: 25 mm) at the 6 simulated locations on the ESD training model using the disposable endoscope (Ambu aScope Gastro, Ambu) and the reusable endoscope (GIF-Q260J, Olympus). A total of 24 lesions were treated by 3 ESD beginners (less than 30 ESD experience) and 3 ESD experts (over 300 ESD experience), each performing on 2 locations (4 lesions).
We evaluated procedure time, dissection speed, en bloc resection rate, perforation rate, scope malfunction rate, and number of scope removals during procedure. Additionally, we administered questionnaires to assess the endoscopists' opinions on each scope, including image visibility, manipulate handle operability, tip lens washing function, the ability of device insertion and removal, and scope operability at each site, rated on a scale of 0-5. The evaluations were classified as low (<2), moderate (2<= and <4), and high (4<=).
Results
All procedures were completed using the assigned scopes. The median procedure time was 24.2 min (range, 14.2-36.5) for the disposable endoscopes (Dispo), slightly longer than 19.6 min (range, 13.5-29.5) for the reusable endoscopes (Reuse). The median dissection speed was 20.3 mm²/min (range, 13.5-34.6) for Dispo and 25.2 mm²/min (range, 16.7-36.3) for Reuse, and the differences were not significant in both (procedure time: p-value=0.284, dissection speed: p=0.379). In the subgroup analysis, Dispo tended to have slightly longer procedure time than Reuse in beginner group (Dispo: 29.5 min [range, 20.0-36.5], Reuse: 25.2 min[range, 16.3-29.5], p=0.206). On the other hands, in expert group there was almost no difference in treatment time (Dispo: 16.4 min [range, 14.2-25.2], Reuse: 16.6 min [range, 13.5-21.1], p=0.453). The en bloc resection rate was 100%, not only for Reuse but also for Dispo. No cases of perforation or scope malfunction were observed in any of the scopes. For either scope, there were no lesions that required removal of the scope due to wiping the adhesion at the tip lens or any other reasons.
The results of the questionnaires were as follows image visibility: Dispo 2.3±0.9, Reuse 4.0±0.6; manipulate handle operability: Dispo 3.5±0.8, Reuse 4.5±0.5; tip lens washing function: Dispo 3.2±1.1, Reuse 3.8±0.9; the ability of device insertion and removal: Dispo 3.3±0.5, Reuse 3.7±0.5; scope operability (evaluated at each site): Dispo 3.3±0.8, Reuse 3.9±0.5. The scores of all items for Dispo were slightly lower than those for Reuse, particularly in terms of screen visibility and usability, but scored moderately well in all categories.
Conclusion
In the training model, the performance of the disposable endoscope in the ESD procedure was acceptable compared to the reusable endoscope. As a next step, we are planning to conduct clinical research.
References
1. U.S. Food and Drug Administration. Infections Associated with Reprocessed Duodenoscopes
2. Han.ZL, et al. Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings. DEN. 11 March 2023: Online ahead of print.
3. Luo.X, et al. Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial. Gastrointest Endosc. 2022 Aug;96(2):250-261.
Disclosure
This research was conducted with a research fund and disposable scopes from Ambu, and with items related to ESD training model from KOTOBUKI Medical.