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CC BY-NC-ND 4.0 · Z Gastroenterol 2022; 60(09): 1314-1319
DOI: 10.1055/a-1555-0568
Originalarbeit

The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial

Die Durchführbarkeit und Sicherheit von Einweg-Endoskopen bei der Untersuchung des oberen Gastrointestinaltrakts im Vergleich zu konventionellen Endoskopen: Eine multizentrische, randomisierte, parallele, Nichtunterlegenheits-Studie
De-feng Li
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
,
Rui-yue Shi
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
,
Yan-hui Tian
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
,
Zheng-lei Xu
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
,
Ying-sheng Zhou
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Xian-jiu Sun
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Jin-wei Cai
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Yuan-yuan Fang
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Huan Peng
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Jia-min Wang
2   Department of Gastroenterology, University of Chinese Academy of Sciences Affiliated Shenzhen Hospital,
,
Tao Dong
3   Shenzhen Pengrui Intelligent Image Co., Ltd,
,
Yong-de Cai
3   Shenzhen Pengrui Intelligent Image Co., Ltd,
,
Jun Yao
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
,
Li-sheng wang
1   Department of Gastroenterology, Shenzhen People's Hospital (The Second Clinical Medical College, Jinan University, The First Affiliated Hospital, Southern University of Science and Technology),
› Author AffiliationsSupported by: Natural Science Foundation of Guangdong Province No.2018A0303100024
Supported by: Technical Research and Development Project of Shenzhen No. JCYJ20150403101028164, No. JCYC201703071009114,No. JCYJ20190807145617113
Supported by: Shenzhen Health Planning Commission Shenzhen Health Planning Commission
Supported by: National Natural Science Foundation of China No.81502040
Supported by: Three Engineering Training Funds in Shenzhen No. SYLY201718, No.SYJY201714 and No.SYLY201801
› Further Information
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Abstract

Background A disposable upper gastrointestinal endoscope can effectively decrease infectious outbreaks associated with endoscope reuse. In the present study, we aimed to evaluate the feasibility and safety of a disposable endoscope for upper gastrointestinal examination.

Methods In a prospective, randomized trial, 144 upper endoscopic procedures were allocated to either the disposable endoscope group or the conventional endoscope group. The primary outcomes were rates of excellent and good image qualities and maneuverability satisfaction. The second outcome included procedure duration, endoscopic diagnosis, and adverse events.

Results A total of 144 subjects were enrolled in the present analysis and prospectively randomized to 2 study groups. Finally, 70 and 69 subjects were enrolled in the novel disposable endoscope group and the conventional endoscope group, respectively, due to the schedule cancellation of 5 subjects. The baseline characteristics of the patients were similar in both groups. The excellent and good image quality rates and maneuverability satisfaction of the novel disposable endoscope were not inferior to the conventional endoscope (p = 0.99 and p = 0.99, respectively). Moreover, no significant between-group difference was observed in the endoscopic results and adverse events (p = 0.30 and p = 1, respectively). However, the procedure duration in the novel disposable endoscope was longer compared with the conventional endoscope (8.40 ± 4.28 min vs. 5.12 ± 2.65 min, p < 0.001).

Conclusions The novel disposable endoscope was as safe, effective, and maneuverable as a conventional endoscope. However, the novel disposable endoscope was associated with a longer procedure duration.

Zusammenfassung

Hintergrund Einweg-Endoskope für den oberen Gastrointestinaltrakt können Infektionsausbrüche, die auf die Wiederverwendung von Endoskopen zurückzuführen sind, wirksam verringern. In der vorliegenden Studie sollte die Durchführbarkeit und Sicherheit von Einweg-Endoskopen bei der Untersuchung des oberen Gastrointestinaltrakts bewertet werden.

Methoden In einer prospektiven, randomisierten Studie wurden 144 endoskopische Eingriffe des oberen Gastrointestinaltrakts entweder der Einweg-Endoskop-Gruppe oder der konventionellen Endoskop-Gruppe zugewiesen. Die primären Endpunkte waren die Rate der guten Bildqualität sowie die Zufriedenheit mit der Manövrierfähigkeit. Zu den zweiten Endpunkten gehörten die Dauer des Eingriffs, die endoskopische Diagnose und unerwünschte Ereignisse.

Ergebnisse Insgesamt wurden 144 Probanden in die vorliegende Studie aufgenommen und prospektiv auf zwei Studiengruppen randomisiert. Da fünf Probanden ausfielen, wurden schließlich 70 Probanden in die Einweg-Endoskop-Gruppe und 69 in die konventionelle Endoskop-Gruppe eingeschlossen. Die Patienten beider Gruppen zeigten ähnliche Ausgangscharakteristika. Die Bildqualität und die Zufriedenheit mit der Manövrierfähigkeit des neuartigen Einweg-Endoskops waren nicht schlechter als bei einem konventionellen Endoskop (P=0,99 bzw. P=0,99). Außerdem wurde bei den endoskopischen Ergebnissen und unerwünschten Ereignissen kein signifikanter Unterschied zwischen den Gruppen beobachtet (P=0,30 bzw. P=1). Allerdings dauerte der Eingriff mit dem neuartigen Einweg-Endoskop länger als mit dem konventionellen Endoskop (8,40 ± 4,28 min vs. 5,12 ± 2,65 min, P < 0,001).

Schlussfolgerungen Das neuartige Einweg-Endoskop war genauso sicher, effektiv und manövrierfähig wie das konventionelle Endoskop. Allerdings war das neuartige Einweg-Endoskop mit einer längeren Verfahrensdauer verbunden.

Schlüsselwörter

neuartiges Einweg-Endoskop - Durchführbarkeit - Sicherheit

Keywords

novel disposable endoscope - feasibility - safety

Supporting information



Publication History

Received: 23 January 2021

Accepted after revision: 08 July 2021

Article published online:
12 November 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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