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Life (Basel, Switzerland) Aug 2023Duodenoscope-related infections are a major concern in medicine and GI endoscopy, especially in fragile patients. Disposable duodenoscopes seem to be the right tool to... (Review)
Review
Duodenoscope-related infections are a major concern in medicine and GI endoscopy, especially in fragile patients. Disposable duodenoscopes seem to be the right tool to minimize the problem: a good choice for patients with many comorbidities or with a high risk of carrying multidrug resistant bacteria. Urgent endoscopy could also be a good setting for the use of single-use duodenoscopes, especially when the risk of the infection cannot be evaluated. Their safety and efficacy in performing ERCP has been proven in many studies. However, randomized clinical trials and comparative large studies with reusable scopes are lacking. Moreover, the present early stage of their introduction on the market does not allow a large economical evaluation for each health system. Thus, accurate economical and safety comparisons with cap-disposable duodenoscopes are needed. Moreover, the environmental impact of single-use duodenoscopes should be carefully evaluated, considering the ongoing climate change. In conclusion, definitive guidelines are needed to choose wisely the appropriate patients for ERCP with disposable duodenoscopes as the complete switch to single-use duodenoscopes seems to be difficult, to date. Many issues are still open, and they need to be carefully evaluated in further, larger studies.
PubMed: 37629551
DOI: 10.3390/life13081694 -
Clinical Endoscopy Mar 2022Unlike simple forward-viewing endoscopes such as gastroscope or colonoscope, duodenoscope houses much more complex design to fulfil its function. This design differences... (Review)
Review
Unlike simple forward-viewing endoscopes such as gastroscope or colonoscope, duodenoscope houses much more complex design to fulfil its function. This design differences leave duodenoscopes more prone to contamination from inadequate disinfection process and potential dissemination of pathogens. Recent reports on dissemination of infection through the duodenoscope mandated an overhaul of duodenoscope utilization including development of a disposable duodenoscope. This article reviews the current state of disposable duodenoscope development, including reported early efficacy as well as its future direction and utilization.
PubMed: 34154307
DOI: 10.5946/ce.2021.075 -
Seminars in Interventional Radiology Aug 2021Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic technique in which a specialized side-viewing endoscope is guided into the duodenum, allowing for... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic technique in which a specialized side-viewing endoscope is guided into the duodenum, allowing for instruments to access the biliary and pancreatic ducts. ERCP was initially developed as a diagnostic tool as computed tomography was in its infancy during that time. ERCP has evolved since its inception in the 1960s to becoming not only a valuable diagnostic resource but now an effective therapeutic intervention in the treatment of various biliary disorders. The most common biliary interventions performed by ERCP include the management of biliary obstructions for benign and malignant indications. Additionally, endoscopic ultrasound (EUS) has been increasingly utilized in diagnosing and intervening on pancreaticobiliary lesion. This article will discuss the various methods currently available for various endoscopic biliary interventions and future interventional techniques. For the management of biliary strictures, EUS can be utilized with fine need aspiration, while ERCP can be used for the placement of various stents and diagnostic modalities. Another example is radiofrequency ablation, which can be used for the treatment of hilar strictures. Achieving bile duct access can be challenging in patients with complicated clinical scenarios; other techniques that can be used for bile duct access include EUS-guided rendezvous approach, transluminal approach, Choleodochoduodenostomy, and hepatogastrostomy, along with gaining access in complicated anatomy such as in patients with Rou-en-Y anatomy. Another useful endoscopic tool is nonsurgical drainage of the gallbladder, which can be a suitable option when patients are not optimal surgical candidates. There has also been an increase in outpatient utilization of ERCP, which was previously seen as a predominantly inpatient procedure in the past. Possible future evolutions of biliary interventions include robotic manipulation of a duodenoscope and direct infusion of chemotherapeutic or immunomodulatory agents into the pancreaticobiliary tree. These advancements will depend on parallel advancements in other imaging and laboratory as well as breakthrough technology or techniques by other disciplines including interventional radiology and minimally invasive surgery.
PubMed: 34393338
DOI: 10.1055/s-0041-1731266 -
Gastrointestinal Endoscopy Jan 2022
Review
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 34487777
DOI: 10.1016/j.gie.2021.08.019 -
American Journal of Infection Control Sep 2022The objectives of this survey study were to assess duodenoscope precleaning and manual cleaning times, identify human factors issues in duodenoscope reprocessing...
BACKGROUND
The objectives of this survey study were to assess duodenoscope precleaning and manual cleaning times, identify human factors issues in duodenoscope reprocessing workflow or ergonomics, and ascertain any best practices in duodenoscope reprocessing.
METHODS
Researchers developed the confidential, qualitative, online Duodenoscope Reprocessing Workflow and Ergonomic Design Human Factors Survey with an intended audience of healthcare workers (HCWs) who routinely perform duodenoscope precleaning or manual cleaning. The unrestricted survey link was distributed to target HCW email addresses in December 2020; the survey closed in January 2021.
RESULTS
Three hundred and forty-one individuals completed the survey. Most respondents complete duodenoscope precleaning in 10 minutes or less and manual cleaning in 16-to-30 minutes. Most respondents' facilities use fixed distal endcap duodenoscopes. Most respondents experience pressure to work faster when cleaning duodenoscopes and reported that cleaning duodenoscopes caused fatigue or discomfort in at least one body part. Mentoring HCWs and retaining experienced staff were 2 primary duodenoscope reprocessing best practices identified by respondents.
DISCUSSION AND CONCLUSIONS
To enhance duodenoscope cleaning, facilities should provide ample reprocessing work spaces with incorporated height-adjustable work surfaces, train HCWs on validated duodenoscope reprocessing instructions, provide step-by-step instructions for HCWs when duodenoscope cleaning is performed, mentor reprocessing HCWs, and retain experienced staff.
Topics: Cross Infection; Disinfection; Duodenoscopes; Equipment Contamination; Ergonomics; Feedback; Health Personnel; Humans; Workflow
PubMed: 35108583
DOI: 10.1016/j.ajic.2022.01.012 -
GE Portuguese Journal of... Aug 2023Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Billroth II gastrectomy is still a challenging procedure. The optimal approach, namely the type of...
INTRODUCTION
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Billroth II gastrectomy is still a challenging procedure. The optimal approach, namely the type of endoscope and sphincter management, has yet to be defined.
AIM
To compare the efficacy and safety of forward-viewing gastroscope and the side-viewing duodenoscope in ERCP of patients with Billroth II gastrectomy.
METHODS
We conducted a retrospective, single-center cohort study of consecutive patients with Billroth II gastrectomy submitted to ERCP in an expert center for ERCP between 2005 and 2021. The outcomes assessed were: papilla identification, deep biliary cannulation, and adverse events (AEs). Multivariate analysis was performed to evaluate potential associations and predictors of the main outcomes.
RESULTS
We included 83 patients with a median age of 73 (IQR 65-81) years. ERCP was performed using side-viewing duodenoscope in 52 and forward-viewing gastroscope in 31 patients. Patients' characteristics were similar in the two groups. The global rate of papilla identification was 66% ( = 55). The rate of deep cannulation was 58% considering all patients and 87% in the subgroup of patients in which the papilla major was identified. Cannulation was performed with standard methods in 65% of cases and with needle-knife fistulotomy in 35%. AEs occurred in 4 patients. There was no difference between duodenoscope and gastroscope in papilla identification (64% [95% CI: 51-77] vs. 71% [55-87]). Although not statistically significant, duodenoscope had a lower deep cannulation rate when considering all patients (52% [15-39] vs. 68% [7-35]) and a higher AEs rate (8% [1-15] vs. 0% [0-1]). In a multivariate analysis, the use of gastroscope significantly increased the deep cannulation rate (OR = 152.62 [2.5-9,283.6]).
CONCLUSION
This study demonstrates that forward-viewing gastroscope is at least as effective and safe as side-viewing duodenoscope for ERCP in patients with Billroth II gastrectomy. Moreover, our study showed that gastroscope is an independent predictor of successful cannulation.
PubMed: 37767310
DOI: 10.1159/000524262 -
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 -
Endoscopy International Open Dec 2020Recent outbreaks of duodenoscope-associated multidrug-resistant organisms (MDROs) have brought attention to the infection risk from procedures performed with... (Review)
Review
Recent outbreaks of duodenoscope-associated multidrug-resistant organisms (MDROs) have brought attention to the infection risk from procedures performed with duodenoscopes. Prior to these MDRO outbreaks, procedures with duodenoscopes were considered safe and low risk for exogenous infection transmission, provided they were performed in strict accordance with manufacturer instructions for use and multisociety reprocessing guidelines. The attention and efforts of the scientific community, regulatory agencies, and the device industry have deepened our understanding of factors responsible for suboptimal outcomes. These include instrument design, reprocessing practices, and surveillance strategies for detecting patient and instrument colonization. Various investigations have made it clear that current reprocessing methods fail to consistently deliver a pathogen-free instrument. The magnitude of infection transmission has been underreported due to several factors. These include the types of organisms responsible for infection, clinical signs presenting in sites distant from ERCP inoculation, and long latency from the time of acquisition to infection. Healthcare providers remain hampered by the ill-defined infectious risk innate to the current instrument design, contradictory information and guidance, and limited evidence-based interventions or reprocessing modifications that reduce risk. Therefore, the objectives of this narrative review included identifying outbreaks described in the peer-reviewed literature and comparing the findings with infections reported elsewhere. Search strategies included accessing peer-reviewed articles, governmental databases, abstracts for scientific conferences, and media reports describing outbreaks. This review summarizes current knowledge, highlights gaps in traditional sources of evidence, and explores opportunities to improve our understanding of actual risk and evidence-based approaches to mitigate risk.
PubMed: 33269310
DOI: 10.1055/a-1264-7173 -
Diagnostics (Basel, Switzerland) Dec 2023Endoscopic retrograde cholangiopancreatography (ERCP) is considered the preferred method for managing biliary obstructions. However, the prevalence of surgically... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) is considered the preferred method for managing biliary obstructions. However, the prevalence of surgically modified anatomies often poses challenges, making the standard side-viewing duodenoscope unable to reach the papilla in most cases. The increasing instances of surgically altered anatomies (SAAs) result from higher rates of bariatric procedures and surgical interventions for pancreatic malignancies. Conventional ERCP with a side-viewing endoscope remains effective when there is continuity between the stomach and duodenum. Nonetheless, percutaneous transhepatic biliary drainage (PTBD) or surgery has historically been used as an alternative for biliary drainage in malignant or benign conditions. The evolving landscape has seen various endoscopic approaches tailored to anatomical variations. Innovative methodologies such as cap-assisted forward-viewing endoscopy and enteroscopy have enabled the performance of ERCP. Despite their utilization, procedural complexities, prolonged durations, and accessibility challenges have emerged. As a result, there is a growing interest in novel enteroscopy and endoscopic ultrasound (EUS) techniques to ensure the overall success of endoscopic biliary drainage. Notably, EUS has revolutionized this domain, particularly through several techniques detailed in the review. The rendezvous approach has been pivotal in this field. The antegrade approach, involving biliary tree puncturing, allows for the validation and treatment of strictures in an antegrade fashion. The EUS-transmural approach involves connecting a tract of the biliary system with the GI tract lumen. Moreover, the EUS-directed transgastric ERCP (EDGE) procedure, combining EUS and ERCP, presents a promising solution after gastric bypass. These advancements hold promise for expanding the horizons of comprehensive and successful biliary drainage interventions, laying the groundwork for further advancements in endoscopic procedures.
PubMed: 38132207
DOI: 10.3390/diagnostics13243623 -
Hepatobiliary & Pancreatic Diseases... Feb 2024Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by...
The outcomes and safety of patients undergoing endoscopic retrograde cholangiopancreatography combining a single-use cholangioscope and a single-use duodenoscope: A multicenter retrospective international study.
BACKGROUND
Duodenoscope-related multidrug-resistant organism (MDRO) infections raise concerns. Disposable duodenoscopes have been recently introduced in the market and approved by regulatory agencies with the aim to reduce the risk of endoscopic retrograde cholangiopancreatography (ERCP) associated infections. The aim of this study was to evaluate the outcome of procedures performed with single-use duodenoscopes in patients with clinical indications to single-operator cholangiopancreatoscopy.
METHODS
This is a multicenter international, retrospective study combining all patients who underwent complex biliopancreatic interventions using the combination of a single-use duodenoscope and a single-use cholangioscope. The primary outcome was technical success defined as ERCP completion for the intended clinical indication. Secondary outcomes were procedural duration, rate of cross-over to reusable duodenoscope, operator-reported satisfaction score (1 to 10) on performance rating of the single-use duodenoscope, and adverse event (AE) rate.
RESULTS
A total of 66 patients (26, 39.4% female) were included in the study. ERCP was categorized according to ASGE ERCP grading system as 47 (71.2%) grade 3 and 19 (28.8%) grade 4. The technical success rate was 98.5% (65/66). Procedural duration was 64 (interquartile range 15-189) min, cross-over rate to reusable duodenoscope was 1/66 (1.5%). The satisfaction score of the single-use duodenoscope classified by the operators was 8.6 ± 1.3 points. Four patients (6.1%) experienced AEs not directly related to the single-use duodenoscope, namely 2 post-ERCP pancreatitis (PEP), 1 cholangitis and 1 bleeding.
CONCLUSIONS
Single-use duodenoscope is effective, reliable and safe even in technically challenging procedures with a non-inferiority to reusable duodenoscope, making these devices a viable alternative to standard reusable equipment.
Topics: Humans; Female; Male; Cholangiopancreatography, Endoscopic Retrograde; Retrospective Studies; Catheterization; Duodenoscopes; Pancreatitis
PubMed: 37100688
DOI: 10.1016/j.hbpd.2023.04.002