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Clinical Endoscopy Jan 2015Biliopancreatic malignancies such as cholangiocarcinoma (CCA) has notoriously been diagnosed late. As such most therapy have been palliative in nature. Cholangioscopy... (Review)
Review
Biliopancreatic malignancies such as cholangiocarcinoma (CCA) has notoriously been diagnosed late. As such most therapy have been palliative in nature. Cholangioscopy allows for an earlier diagnosis to be made. Brachytherapy with the insertion of catheter with iridium-132 seeds, percutaneously or through endoscopic retrograde cholangiopancreatography (ERCP) was the earliest ablative techniques used. It has been shown to have a beneficial effect only in prolonging survival. Photodynamic therapy (PDT) has also been used for several years. stenting with PDT versus stenting alone for unresectable CCA showed a marked survival benefit with the addition of PDT. However the most exciting endoscopic ablative modality appears to be intraductal radiofrequency ablation using the Habib catheter and device. Several case series have shown the effectiveness of this technique in ablating tumors. This technique is evolving and coupled with early diagnosis of CCA through cholangioscopy will allow for a curative therapy. The crux to the effective treatment of early cancerous lesions in the bile or pancreatic duct is the early diagnosis of such lesions. Effective endoscopic ablative therapy is now available with the advent of radiofrequency ablation probes that can be passed through the duodenoscope via ERCP.
PubMed: 25674521
DOI: 10.5946/ce.2015.48.1.15 -
Digestive Endoscopy : Official Journal... Apr 2018Bile duct stones in patients with surgically altered anatomy still pose a challenge to endoscopists. For successful endoscopic management of bile duct stones, there are... (Review)
Review
Bile duct stones in patients with surgically altered anatomy still pose a challenge to endoscopists. For successful endoscopic management of bile duct stones, there are multiple hurdles: Intubation to the afferent limb, biliary cannulation, ampullary intervention and stone extraction. The major advancement in this area is the development of dedicated device-assisted endoscopes for endoscopic retrograde cholangiopancreatography (ERCP). In patients with Billroth II reconstruction, a high technical success rate is reported using a duodenoscope but can be complicated by a potentially high perforation rate. In patients with Roux-en-Y reconstruction, device-assisted ERCP shows high technical success and low adverse event rates. Meanwhile, endoscopic papillary large balloon dilation enables safe and effective stone extraction with less use of endoscopic mechanical lithotripsy in patients with a dilated distal bile duct, but intraductal lithotripsy is sometimes necessary for management of very large bile duct stones. In cases with difficult stones, alternative approaches such as laparoscopy-assisted ERCP and endoscopic ultrasound (EUS)-guided intervention are increasingly reported with preliminary but promising results. However, comparative studies are still lacking in this area and prospective randomized controlled trials are warranted in terms of safety, efficacy and cost-effectiveness.
Topics: Anastomosis, Roux-en-Y; Bile Ducts; Cholangiopancreatography, Endoscopic Retrograde; Endoscopy; Female; Follow-Up Studies; Gallstones; Humans; Lithotripsy; Male; Postoperative Complications; Risk Assessment; Sphincterotomy, Endoscopic; Time Factors; Treatment Outcome
PubMed: 29658650
DOI: 10.1111/den.13022 -
American Journal of Infection Control Apr 2017Current professional guidelines recommend a maximum hang time for reprocessed duodenoscopes of 5-14 days. We sought to study the association between hang time and risk...
BACKGROUND
Current professional guidelines recommend a maximum hang time for reprocessed duodenoscopes of 5-14 days. We sought to study the association between hang time and risk of duodenoscope contamination.
METHODS
We analyzed cultures of the elevator mechanism and working channel collected in a highly standardized fashion just before duodenoscope use. Hang time was calculated as the time from reprocessing to duodenoscope sampling. The relationship between hang time and duodenoscope contamination was estimated using a calculated correlation coefficient between hang time in days and degree of contamination on the elevator mechanism and working channel.
RESULTS
The 18 study duodenoscopes were cultured 531 times, including 465 (87.6%) in the analysis dataset. Hang time ranged from 0.07-39.93 days, including 34 (7.3%) with hang time ≥7.00 days. Twelve cultures (2.6%) demonstrated elevator mechanism and/or working channel contamination. The correlation coefficients for hang time and degree of duodenoscope contamination were very small and not statistically significant (-0.0090 [P = .85] for elevator mechanism and -0.0002 [P = 1.00] for working channel). Odds ratios for hang time (dichotomized at ≥7.00 days) and elevator mechanism and/or working channel contamination were not significant.
CONCLUSIONS
We did not find a significant association between hang time and risk of duodenoscope contamination. Future guidelines should consider a recommendation of no limit for hang time.
Topics: Duodenoscopes; Equipment Contamination; Microbiological Techniques; Risk Assessment; Time Factors
PubMed: 28034537
DOI: 10.1016/j.ajic.2016.11.021 -
Gastrointestinal Endoscopy Aug 2018Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key...
BACKGROUND AND AIMS
Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assessed the long-term results and impact of key interventions in the optimization of a rigorous "culture and quarantine" program for duodenoscope reprocessing.
METHODS
We reviewed a prospectively collected, quality assurance database of all duodenoscope cultures (n = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high-volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use.
RESULTS
A total of 4307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a .697% high-level disinfection defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures.
CONCLUSIONS
Withdrawal of duodenoscopes with a high rate of culture positivity and optimizing manual cleaning practices have contributed to an overall decline in the high-level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.
Topics: Bacteriological Techniques; Cross Infection; Disinfection; Drug Resistance, Multiple, Bacterial; Duodenoscopes; Equipment Contamination; Humans; Quarantine
PubMed: 29476846
DOI: 10.1016/j.gie.2018.02.015 -
Current Opinion in Gastroenterology Sep 2020The elevator mechanism of the duodenoscope was the focus of endoscopically transmitted infections prior to the COVID-19 pandemic. Since that time, the 'suspicious... (Review)
Review
PURPOSE OF REVIEW
The elevator mechanism of the duodenoscope was the focus of endoscopically transmitted infections prior to the COVID-19 pandemic. Since that time, the 'suspicious suspects' in the endoscopy unit have grown in number in the eyes of both patients and endoscopists.
RECENT FINDINGS
This review summarizes the existing guidelines related to infection control in the endoscopy unit and emerging technologies to address gaps, identifies recommendations proposed during the COVID-19 pandemic, and reminds the reader that infection prevention has not changed since the emergence of COVID-19, only the importance of infection prevention has increased in visibility.
SUMMARY
Infection prevention has been and will always be necessary in the gastrointestinal endoscopy unit. Although outbreaks of antibiotic-resistant organisms and infectious diseases like COVID-19 raise the profile of infection control, there have been no major changes to infection control practice recommendations because of the global pandemic. The history of lapses in infection control, persistent contamination of reprocessed endoscopes, and failure of many endoscopy units to identify certain endoscopic procedures as aerosol-generating procedures prior to the pandemic emphasize the need for better knowledge and implementation of infection control practices within endoscopy units.
Topics: Betacoronavirus; COVID-19; Coronavirus Infections; Cross Infection; Disinfection; Duodenoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans; Infection Control; Pandemics; Pneumonia, Viral; Practice Guidelines as Topic; SARS-CoV-2
PubMed: 32739998
DOI: 10.1097/MOG.0000000000000669 -
BMJ Open Gastroenterology 2019Cleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types... (Review)
Review
BACKGROUND
Cleaning and high-level disinfection have been the standard in the USA and other countries for reprocessing flexible endoscopes, including duodenoscopes and other types of gastrointestinal endoscopes. For decades, this practice has been a cornerstone for infection prevention in the endoscopic setting. However, amid recent reports associating the use of duodenoscopes with infections and outbreaks of carbapenem-resistant (CRE) and related multidrug-resistant organisms (MDROs), reasonable questions about the adequacy of current practices for reprocessing duodenoscopes have emerged.
OBJECTIVES
To review and evaluate the adequacy of current reprocessing practices for preventing duodenoscopes from transmitting CRE and related MDROs.
METHODS
The MEDLINE/PubMed database was searched to identify published cases associating confirmed (or suspected) infections of CRE or a related MDRO with exposure to a duodenoscope since 2012, when duodenoscopes became a recognised risk factor for the transmission of CRE. The Internet was also searched to identify news articles and other reports documenting eligible cases occurring during this same timeframe but not identified during the MEDLINE database's search. The Food and Drug Administration's (FDA) medical device database was queried to identify regulatory reports describing these same types of cases, also recorded since 2012. The clinical and reprocessing details of each eligible case were reviewed to identify (when possible): (a) the reprocessing method (e.g., high-level disinfection) performed at the time of the infections, (b) whether the facility's compliance with the manufacturer's reprocessing instructions was confirmed, and (c) the measure(s) or corrective action(s) the facility implemented to prevent additional multidrug-resistant infections.
RESULTS
Seventeen cases in the USA and six in other countries (primarily Europe) associating infections (and colonizations) of CRE or a related MDRO with exposure to a duodenoscope were reviewed. Fourteen of these 23 outbreaks were caused by CRE, and six by a related MDRO. Two of these six latter cases identified carrying the gene as the pathogen. For 12 of these 23 cases, it was reported or implied that the duodenoscope was being high-level disinfected at the time of the infections, consistent with published guidelines. For the remaining 11 cases, the associated report(s) did not clearly identify how the duodenoscope was being reprocessed at the time of the infections (although it may be reasonably concluded that at least some, if not all, of these 11 cases involved high-level disinfection).Further, eight of the 23 cases reported the duodenoscope was being reprocessed in accordance with the manufacturer's instructions for use (and professional guidelines) at the time of the infections. Seven of the cases discussed the design of the duodenoscope (eg, the forceps elevator mechanism) in the context of reprocessing and the infections. Three of the cases identified one or more reprocessing lapses, including inadequate cleaning, delayed reprocessing and improper drying and/or storage of the duodenoscope. Most of these 23 cases were associated with exposure to a duodenoscope model featuring a sealed elevator-wire channel. Six of the cases reported adopting (or in one case supplementing high-level disinfection with) ethylene oxide (EO) gas sterilisation of the duodenoscope, with at least three reporting this measure terminated the outbreak. Other measures adopted to prevent additional infections included removing the implicated duodenoscope from use, re-training staff about proper cleaning, microbiological culturing of the duodenoscope and returning the duodenoscope to the manufacturer for evaluation, maintenance and/or repair.
CONCLUSIONS
This study's findings suggest current reprocessing practices may not always be sufficiently effective to prevent a duodenoscope from transmitting CRE and related MDROs, at least in some circumstances including an outbreak setting. Factors this review identifed that may contribute to the device remaining contaminated after reprocessing include the device's design; breaches of recommended reprocessing guidelines (eg, inadequate manual cleaning, delayed reprocessing or improper device storage); damage to the device; lacking servicing, maintenance or repair; and/or the presence of biofilms. Measures that can mitigate the impact of these and other reprocessing challenges and reduce, if not eliminate, the risk of transmission of CRE or a related MDRO by a duodenoscope include the use of EO gas sterilization (or another comparably effective process or method). In 2015, the FDA suggested healthcare facilities consider performing at least one of four supplemental measures, which include EO gas sterilisation, to improve the effectiveness of duodenoscope reprocessing. Whether the FDA and Centers for Disease Control and Prevention might reclassify duodenoscopes as devices requiring sterilisation is currently unresolved.
PubMed: 31423318
DOI: 10.1136/bmjgast-2019-000282 -
Endoscopy International Open Sep 2023The costs of reusable endoscope reprocessing have been evaluated, yet external validity of the findings remains challenging. The aim of this study was to assess the...
The costs of reusable endoscope reprocessing have been evaluated, yet external validity of the findings remains challenging. The aim of this study was to assess the costs of purchase, maintenance, microbiological control, and reprocessing of a reusable duodenoscope per endoscopic retrograde cholangiopancreatography (ERCP) in France. Study findings exclude the costs of infection, downtime due to breakdown, reprocessing single-use material disposal, and device disposal, all of which should also be considered. The study encompassed both observational and theoretical approaches. Observational data were collected in four hospitals, from December 2019 to December 2020, with an ad hoc survey, based on 2016 and 2018 national guidelines for duodenoscope reprocessing. Costs were modeled, using the same guidelines, assuming a mean workload of 223 ERCP/duodenoscope/year. The mean observed cost of purchase, maintenance, microbiological control, reprocessing (human resources and consumables), and overhead (additional 35%) with a reusable duodenoscope was €80.23 (standard deviation €3.77) per ERCP. The corresponding mean theoretical cost was €182.71 for manual reprocessing without endoscope drying cabinet (EDC), €191.36 for manual reprocessing with EDC, €235.25 for automated endoscope reprocessing (AER) without EDC, and €253.62 for AER with EDC. Because procedures, equipment, volume activity, number of duodenoscopes, human resources, and internal work organizations are hospital-dependent, observed costs varied between hospitals. Theoretical costs were higher than observed costs, showing that the theoretical approach is not sufficient. Hypotheses to explain the difference between the two approaches include failing to measure some costs in the survey and challenges in guideline implementation.
PubMed: 37942444
DOI: 10.1055/a-2153-7016 -
Techniques and Innovations in... 2021Over 16 million cases worldwide, severe acute respiratory syndrome coronavirus 2 has profoundly affected healthcare as we know it. Given reports of gastrointestinal... (Review)
Review
Over 16 million cases worldwide, severe acute respiratory syndrome coronavirus 2 has profoundly affected healthcare as we know it. Given reports of gastrointestinal involvement and viral shedding in the stool, it is unsurprising there are concerns that endoscopic equipment may be a potential vector of viral transmission. Here, we provide an overview of existing practices for endoscope reprocessing, recent developments in the field, and challenges in the COVID-19 environment. Current multi-society guidelines do not advise any change to endoscope disinfection protocols but emphasize strict adherence to recommended practices. However, endoscopy reprocessing staff may benefit from supplemental personal protective equipment measures, especially in high risk situations. Because thorough endoscope reprocessing is highly operator dependent, adequate training of personnel is critical for proper manual cleaning and disinfection of endoscopes that have potential to harbor virus. Bacterial contamination of duodenoscopes has caused outbreaks of infection from multidrug-resistant organisms, highlighting vulnerable areas. The emphasis of current studies is on optimization of disinfection and drying, minimization of simethicone use, and on quality control of endoscope reprocessing with sampling and microbiological culturing. Recent advances include novel approaches to endoscope sterilization, infection barrier methods, and design of partially or fully disposable duodenoscopes. Overall, the available data indicate that, when correctly executed, current reprocessing practices are sufficient in preventing SARS-COV-2 transmission.
PubMed: 33103131
DOI: 10.1016/j.tige.2020.10.001 -
World Journal of Gastrointestinal... May 2015Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted... (Review)
Review
Peroral cholangioscopy (POC) is an important tool for the management of a selected group of biliary diseases. Because of its direct visualization, POC allows targeted diagnostic and therapeutic procedures. POC can be performed using a dedicated cholangioscope that is advanced through the accessory channel of a duodenoscope or via the insertion of a small-diameter endoscope directly into the bile duct. POC was first described in the 1970s, but the use of earlier generation devices was substantially limited by the cumbersome equipment setup and high repair costs. For nearly ten years, several technical improvements, including the single-operator system, high-quality images, the development of dedicated accessories and the increased size of the working channel, have led to increased diagnostic accuracy, thus assisting in the differentiation of benign and malignant intraductal lesions, targeting biopsies and the precise delineation of intraductal tumor spread before surgery. Furthermore, lithotripsy of difficult bile duct stones, ablative therapies for biliary malignancies and direct biliary drainage can be performed under POC control. Recent developments of new types of conventional POCs allow feasible, safe and effective procedures at reasonable costs. In the current review, we provide an updated overview of POC, focusing our attention on the main current clinical applications and on areas for future research.
PubMed: 25992189
DOI: 10.4253/wjge.v7.i5.510 -
Clinical Endoscopy Nov 2022Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass anatomy is a well-documented challenge. Traditionally, this problem has... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y gastric bypass anatomy is a well-documented challenge. Traditionally, this problem has been overcome with adjunctive techniques, such as device-assisted ERCP, including double-balloon or single-balloon enteroscopy and laparoscopy-assisted transgastric ERCP. Endoscopic ultrasound-directed transgastric ERCP (EDGE) is a novel technique that enables access to the ampulla using a duodenoscope without surgical intervention and has shown high clinical and technical success rates in recent studies. However, this approach is technically demanding, necessitating a thorough understanding of the gastrointestinal anatomy as well as high operator experience. In this review, we provide a technical overview of EDGE in parallel with our personal experience at our center and propose a simple algorithm to select patients for its appropriate application. In conjunction, the outcomes of EDGE compared with those of device-assisted and laparoscopy-assisted transgastric ERCP will be discussed.
PubMed: 36464820
DOI: 10.5946/ce.2022.114