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Surgical Laparoscopy, Endoscopy &... Jun 2024Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news...
OBJECTIVE
Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes.
MATERIALS AND METHODS
For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023.
RESULTS
In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis.
CONCLUSIONS
After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.
Topics: Disposable Equipment; Humans; Equipment Reuse; Endoscopes, Gastrointestinal; Equipment Design; Gastrointestinal Diseases; Endoscopy, Gastrointestinal; Duodenoscopes
PubMed: 38767593
DOI: 10.1097/SLE.0000000000001278 -
Gastrointestinal Endoscopy Dec 2023The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
The current standard of practice is to use a duodenoscope for the evaluation of the major duodenal papilla (MDP). Recently, cap-assisted endoscopy (CAE), which uses a transparent cap at the tip of a standard front-viewing endoscope, has emerged as an alternative.
METHODS
A systematic literature search was performed in several databases from inception to January 2023 to identify studies evaluating the efficacy of CAE for the evaluation of the MDP.
RESULTS
Nine studies including 806 patients met our inclusion criteria. The pooled rate of technical success for CAE was 93.2% (95% confidence interval, 85.6-96.9; I = 84.6%). A subgroup analysis comparing CAE with a standard endoscope showed higher odds for the evaluation of the MDP with CAE (but not a duodenoscope, which was better than CAE) with an odds ratio of 57.294 (95% confidence interval, 17.767-184.755; I = 45.303%).
CONCLUSIONS
CAE offers a significant advantage with high rates of complete MDP evaluation compared with standard forward-viewing endoscopy. However, CAE is associated with lower rates of success when compared with side-viewing endoscopes.
Topics: Humans; Ampulla of Vater; Endoscopy, Gastrointestinal; Endoscopes; Duodenoscopes
PubMed: 37544335
DOI: 10.1016/j.gie.2023.07.050 -
Digestive and Liver Disease : Official... Jan 2024Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary... (Meta-Analysis)
Meta-Analysis Review
Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.
BACKGROUND
Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
METHODS
Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP.
RESULTS
Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08).
CONCLUSIONS
The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.
Topics: Male; Humans; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Catheterization
PubMed: 37003844
DOI: 10.1016/j.dld.2023.02.022