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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 -
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 -
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 -
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 -
The Journal of Hospital Infection Apr 2024Contamination rates reported in the literature for patient-ready flexible endoscopes vary from 0.4% to 49%. Unfortunately, the comparison and interpretation of these...
BACKGROUND
Contamination rates reported in the literature for patient-ready flexible endoscopes vary from 0.4% to 49%. Unfortunately, the comparison and interpretation of these results is almost impossible since several factors including sampling and culturing methods, target levels for contamination, or definition of indicator micro-organisms vary widely from one study to the other.
AIM
To compare the efficacy of six duodenoscope sampling and culturing methods by means of extraction efficacy comparison, while at the same time identifying key parameters that provide optimal microbial recovery.
METHODS
The duodenoscope sample extraction efficacy of each method was assessed using the repetitive recovery method described in ISO 11737-1: 2018.
FINDINGS
Mean overall bioburden extraction efficacy varied from 1% for the Australian method to 39% for the French one. The lowest endoscope sample extraction efficacy was associated with the absence of any neutralizer, friction, or tensioactive agent, and when only a small portion of the sampling solution collected was inoculated on to culture media. The efficacy of the sampling and culturing methods also varied according to the nature of micro-organisms present in the endoscope, and the time between sampling and culturing.
CONCLUSION
This study supports the need for a harmonized and standardized sampling and culturing method for flexible endoscopes.
PubMed: 38649121
DOI: 10.1016/j.jhin.2024.03.017 -
Endoscopy Dec 2023The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde... (Clinical Trial)
Clinical Trial
BACKGROUND
The first commercialized single-use duodenoscope was cleared by the US Food and Drug Administration in December 2019. Data regarding endoscopic retrograde cholangiopancreatography (ERCP) using a single-use duodenoscope are needed on a broader range of cases conducted by endoscopists with varying levels of experience in a wide range of geographic areas.
METHODS
61 endoscopists at 22 academic centers in 11 countries performed ERCP procedures in adult patients aged ≥ 18. Outcomes included ERCP completion for the intended indication, rate of crossover to a reusable endoscope, device performance ratings, and serious adverse events (SAEs).
RESULTS
Among 551 patients, 236 (42.8 %) were aged > 65, 281 (51.0 %) were men, and 256 (46.5 %) had their procedure as an inpatient. ERCPs included 196 (35.6 %) with American Society for Gastrointestinal Endoscopy complexity of grades 3-4. A total of 529 ERCPs (96.0 %) were completed: 503 (91.3 %) using only the single-use duodenoscope, and 26 (4.7 %) with crossover to a reusable endoscope. There were 22 ERCPs (4.0 %) that were not completed, of which 11 (2.0 %) included a crossover and 11 (2.0 %) were aborted cases (no crossover). Median ERCP completion time was 24.0 minutes. Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10 [best]). SAEs were reported in 43 patients (7.8 %), including 17 (3.1 %) who developed post-ERCP pancreatitis.
CONCLUSIONS
In academic medical centers over a wide geographic distribution, endoscopists with varying levels of experience using the first marketed single-use duodenoscope had good ERCP procedural success and reported high performance ratings for this device.
Topics: Adult; Male; Humans; Female; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Endoscopy, Gastrointestinal; Pancreatitis
PubMed: 37463599
DOI: 10.1055/a-2131-7180 -
Journal of Clinical Gastroenterology Apr 2024Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed...
Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed every year, and most are performed using a reusable flexible duodenoscope. The innovation of disposable duodenoscopes has changed the dynamic in the advanced endoscopy field of study to primarily reduce or eliminate the risk of cross-contamination between patients. Many factors affect whether institutions can convert from standard reusable duodenoscopes to single-use duodenoscopes including the cost of the devices, reimbursement from insurance companies for the new devices, and the overall environmental impact. However, the reduction of cross-contamination leading to active infection in patients, environmental waste produced with high-level disinfection procedures, staff and equipment required for reprocessing, and the inability to frequently upgrade duodenoscopes for optimal performance are all factors that favor transitioning to single-use duodenoscopes. As these devices are new to the field of gastroenterology, the purpose of this review is to analyze the advantages and disadvantages of transitioning to single-use devices and a brief mention of alternative options for institutions unable to make this change.
PubMed: 38567887
DOI: 10.1097/MCG.0000000000001994 -
VideoGIE : An Official Video Journal of... Aug 2023Duodenal polyps have a reported incidence of 0.3% to 4.6%. Sporadic, nonampullary duodenal adenomas (SNDAs) comprise less than 10% of all duodenal polyps, and ampullary... (Review)
Review
BACKGROUND AND AIMS
Duodenal polyps have a reported incidence of 0.3% to 4.6%. Sporadic, nonampullary duodenal adenomas (SNDAs) comprise less than 10% of all duodenal polyps, and ampullary adenomas are even less common. Nonetheless, the incidence continues to rise because of widespread endoscopy use. Duodenal polyps with villous features or those that are larger than 10 mm may raise concern for malignancy and require removal. We demonstrate endoscopic resection of SNDAs and ampullary adenomas using some of our preferred techniques.
METHODS
The duodenum has several components that can make EMR of duodenal polyps technically challenging. Not only does the duodenum have a thin muscle layer, but it is also highly mobile and vascular, which may explain higher rates of perforation and bleeding of duodenal EMR reported in the literature compared with colon EMR. A standard adult gastroscope with a distal cap is commonly used for duodenal EMRs. Based on the location, however, side-viewing duodenoscopes or pediatric colonoscopes may be used. To prepare for EMR, a submucosal injection is performed for an adequate lift. The polyp is then resected via stiff monofilament snares and subsequently closed with hemostatic clips if feasible. The ampullectomy technique differs slightly from duodenal EMRs and carries the additional risk of pancreatitis. Submucosal injection in the ampulla may not lift well; thus, its utility is debatable. Biliary sphincterotomy should be performed, and based on endoscopist preference, the pancreatic duct (PD) guidewire can be left during resection to maintain access. After resection, a PD stent is placed to minimize pancreatitis risk.
RESULTS
The video shows the aforementioned duodenal EMR techniques. Two clips of ampullectomy are also shown in the video.
CONCLUSIONS
A few common techniques used to perform duodenal EMR and ampullectomy are highlighted in the video. It is important to understand and manage adverse events associated with these procedures and to have established surveillance plans.
PubMed: 37575136
DOI: 10.1016/j.vgie.2023.05.006 -
Gut Mar 2024Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated... (Review)
Review
OBJECTIVE
Contaminated duodenoscopes caused several hospital outbreaks. Despite efforts to reduce contamination rates, 15% of patient-ready duodenoscopes are still contaminated with gastrointestinal microorganisms. This study aimed to provide an overview of duodenoscope contamination over time, identify risk factors and study the effects of implemented interventions.
DESIGN
Duodenoscope culture sets between March 2015 and June 2022 at a Dutch tertiary care centre were analysed. Contamination was defined as (1) the presence of microorganisms of oral or gastrointestinal origin (MGO) or (2) any other microorganism with ≥20 colony-forming units/20 mL (AM20). A logistic mixed effects model was used to identify risk factors and assess the effect of interventions, such as using duodenoscopes with disposable caps, replacing automated endoscope reprocessors (AER) and conducting audits in the endoscopy department.
RESULTS
A total of 404 culture sets were analysed. The yearly contamination rate with MGO showed great variation, ranging from 14.3% to 47.5%. Contamination with AM20 increased up to 94.7% by 2022. For both MGO and AM20, the biopsy and suction channels were the most frequently contaminated duodenoscope components. The studied interventions, including audits, AER replacement and implementation of duodenoscopes with disposable caps, did not show a clear association with contamination rates.
CONCLUSION
Duodenoscope contamination remains a significant problem, with high contamination rates despite several interventions. Reprocessing the biopsy and suction channels is especially challenging. Changes in the design of reusable duodenoscopes, such as enabling sterilisation or easily replaceable channels, are necessary to facilitate effective duodenoscope reprocessing and to eliminate the risk of duodenoscope-associated infections.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Duodenoscopes; Magnesium Oxide; Retrospective Studies; Tertiary Care Centers
PubMed: 38182137
DOI: 10.1136/gutjnl-2023-330355