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American Journal of Infection Control Oct 2019Multiple outbreaks from contaminated duodenoscopes have been reported since 2008. This study assessed results of a multicenter comprehensive quality control (QC) program...
BACKGROUND
Multiple outbreaks from contaminated duodenoscopes have been reported since 2008. This study assessed results of a multicenter comprehensive quality control (QC) program to enhance manual cleaning efficacy of duodenoscopes in endoscopy units.
METHODS
Digestive Endoscopy Society of Taiwan implemented a QC program with adenosine triphosphate (ATP) testing of patient-used duodenoscopes in 2 rounds of on-site audit in endoscopy units. ATP samples were obtained from 5 different locations of the duodenoscope after manual cleaning. Duodenoscope exceeding ATP benchmark of 200 relative light units indicated inadequate manual cleaning.
RESULTS
During the first round on-site audit, 12 hospitals and 27 patient-used duodenoscopes were analyzed. Distal end outer surface (29.6%), elevator mechanism (51.9%), distal attachment cap (59.3%), elevator wire channel (37.0%), and suction biopsy channel (37.0%) were inadequately cleaned. Overall, 19 (70.4%) duodenoscopes had inadequate manual cleaning, ranging widely from 0%-100% among endoscopy units. During the follow-up on-site audit, 32 patient-used duodenoscopes were analyzed, and 6 (18.8%) had inadequate manual cleaning.
CONCLUSIONS
ATP tests may provide real-time feedback on the cleaning efficacy of patient-used duodenoscopes. Implementing a comprehensive QC program could enhance the efficacy of manual cleaning in endoscopy units.
Topics: Adenosine Triphosphate; Cross Infection; Disinfection; Duodenoscopes; Endoscopy; Equipment Contamination; Humans; Infection Control; Prospective Studies; Quality Control; Taiwan
PubMed: 31126624
DOI: 10.1016/j.ajic.2019.03.029 -
Gastrointestinal Endoscopy Jun 2019
Topics: Aged, 80 and over; Cholangiopancreatography, Endoscopic Retrograde; Cholangitis; Choledocholithiasis; Duodenoscopes; Esophageal Mucosa; Humans; Iatrogenic Disease; Lacerations; Male; Stents; Tomography, X-Ray Computed
PubMed: 30822419
DOI: 10.1016/j.gie.2019.02.022 -
BMC Gastroenterology Mar 2020Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized...
BACKGROUND
Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes.
METHODS
A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use.
DISCUSSION
The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level.
TRIAL REGISTRATION
This trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disposable Equipment; Duodenoscopes; Equipment Contamination; Equipment Design; Infection Control; Randomized Controlled Trials as Topic
PubMed: 32164535
DOI: 10.1186/s12876-020-01200-7 -
Endoscopy Oct 2020
Topics: Betacoronavirus; COVID-19; Cholangiopancreatography, Endoscopic Retrograde; Coronavirus Infections; Duodenoscopes; Humans; Pandemics; Pneumonia, Viral; SARS-CoV-2
PubMed: 32967025
DOI: 10.1055/a-1194-4745 -
The Lancet. Gastroenterology &... Jul 2018Highly publicised outbreaks of various infections related to the use of duodenoscopes have increased public awareness of the once arcane and largely ignored subject of... (Review)
Review
Highly publicised outbreaks of various infections related to the use of duodenoscopes have increased public awareness of the once arcane and largely ignored subject of endoscope reprocessing. Since 2015, national professional societies, multiple federal agencies, and even the US Senate have written reports and guidelines on duodenoscope reprocessing. However, their recommendations are sometimes contradictory and difficult to implement, and new research on the topic is published regularly which further complicates the situation. With this flood of new and sometimes contradictory information, clinicians can feel confused about how to assure the safety of their patients undergoing duodenosocopy. This Review summarises the most salient current research on duodenoscope-associated outbreaks and reprocessing, and aims to provide clinicians with practical information applicable to their practice.
Topics: Bacterial Infections; Disinfection; Duodenoscopes; Equipment Contamination; Equipment Design; Equipment Reuse; Equipment Safety; Humans; Quality Control; Sterilization
PubMed: 29893234
DOI: 10.1016/S2468-1253(18)30122-5 -
Revista Espanola de Enfermedades... Dec 2021A 54-year-old male was admitted due to painless jaundice to our hospital four weeks after undergoing liver transplantation. Magnetic resonance imaging cholangiography...
A 54-year-old male was admitted due to painless jaundice to our hospital four weeks after undergoing liver transplantation. Magnetic resonance imaging cholangiography demonstrated the presence of an anastomotic biliary stenosis.
Topics: Cholangiography; Cholestasis; Constriction, Pathologic; Duodenoscopes; Humans; Liver Transplantation; Male; Middle Aged; Postoperative Complications
PubMed: 34428914
DOI: 10.17235/reed.2021.8201/2021 -
Endoscopy Oct 2020
Topics: Betacoronavirus; COVID-19; China; Cholangiopancreatography, Endoscopic Retrograde; Coronavirus Infections; Disease Outbreaks; Duodenoscopes; Endoscopy, Gastrointestinal; Humans; Infections; Pandemics; Pneumonia; Pneumonia, Viral; SARS-CoV-2
PubMed: 32967024
DOI: 10.1055/a-1180-8681 -
Current Opinion in Gastroenterology Sep 2021Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from... (Review)
Review
PURPOSE OF REVIEW
Given the growing concerns about infection transmission from use of contaminated reusable duodenoscopes, technological advancements have been made that vary from modifications of existing designs to development of single-use devices.
RECENT FINDINGS
To circumvent mechanical limitations that preclude access to critical areas of a duodenoscope to perform thorough cleaning and disinfection, single-use disposable duodenoscopes have been developed. A thorough assessment of this technology is limited by the minimal published data that is currently available. This opinion assesses the current technical functionality of these devices, potential for further improvements, implications for healthcare economics and the future of gastrointestinal endoscopy.
SUMMARY
Currently available data suggest that majority of endoscopic retrograde cholangiopancreatography procedures can be safely performed using single-use duodenoscopes. The ability to improve technical functionality, incorporate futuristic technology and secure financial reimbursement from insurance carriers will largely define the future prospects of this recent innovation.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Endoscopy, Gastrointestinal; Equipment Contamination; Humans
PubMed: 34010243
DOI: 10.1097/MOG.0000000000000755 -
Acta Gastro-enterologica Belgica 2017Endoscopic retrograde cholangiopancreatography (ERCP) in Billroth II patients is challenging and different endoscopes can be used. We retrospectively analysed 67 ERCP... (Comparative Study)
Comparative Study
Endoscopic retrograde cholangiopancreatography (ERCP) in Billroth II patients is challenging and different endoscopes can be used. We retrospectively analysed 67 ERCP procedures in 38 Billroth II patients focussing on endoscope type and respective technical success and adverse event rate. 33 (49.2 %) ERCPs were performed using a duodenoscope, 87.9 % were successful and 3 were completed with the single-balloon enteroscope. 28 (41.8 %) ERCPs were performed with the single-balloon enteroscope, 82.1 % were successful and 2 were completed with a paediatric colonoscope. For 6 (9.0 %) ERCPs a paediatric colonoscope was used but only 3 (50.0 %) were successful. Overall technical success rate was 82.1 % without difference between the success rate of the duodenoscope and the single-balloon enteroscope. Overall adverse event rate was 10.5 %: 6.1 % duodenoscope,10.7 % single-balloon enteroscope, 33.3 % paediatric colonoscope. The duodenoscope allowed all conventional ERCP procedures, whereas the singleballoon enteroscope required dedicated ERCP catheters and did not allow metallic stent placement. However, the single-balloon enteroscope facilitated access to the papilla and sphincteroplasty allowed direct cholangioscopy. ERCP indications were bile duct stones (53.7 %), cholangitis (20.9 %), chronic pancreatitis (20.9 %), pancreatic cancer (1.5 %) and liver transplantation (3%). Therapeutic ERCP success rate is high in patients with Billroth II gastrectomy using either a conventional duodenoscope or the single-balloon enteroscope, with an acceptable and comparable adverse event rate. The choice of endoscope may depend on local experience, post-operative anatomy and therapeutic indication.
Topics: Aged; Aged, 80 and over; Balloon Enteroscopy; Belgium; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Female; Fluoroscopy; Gastrectomy; Gastroenterostomy; Humans; Male; Middle Aged; Retrospective Studies; Risk Factors; Treatment Outcome
PubMed: 29560645
DOI: No ID Found -
Journal of Clinical Gastroenterology Mar 2016The aim of this study was to evaluate the usefulness of the conventional side-viewing duodenoscope for successful endoscopic retrograde cholangiopancreatography (ERCP)...
OBJECTIVES
The aim of this study was to evaluate the usefulness of the conventional side-viewing duodenoscope for successful endoscopic retrograde cholangiopancreatography (ERCP) in postgastrectomy patients.
METHODS
A total of 220 consecutive patients with bile duct stones or a distal common bile duct stricture who had previously undergone gastrectomy and were referred for ERCP were analyzed for the outcome of their ERCP. All ERCP procedures were performed using a conventional side-viewing duodenoscope. In patients who had undergone a Billroth II gastroenterostomy and total gastrectomy with Roux-en-Y reconstruction, we also used the procedure of retrieval balloon-assisted enterography.
RESULTS
The study group included 220 patients who had previously undergone gastrectomy (77 women and 143 men; mean age, 72.2 y; range, 11 to 93 y). The overall enterography success rate was 90.5% (199/220), and the diagnostic and ERCP success rates were both 88.6% (195/220). Endoscopy was unsuccessful in 21 patients who received Billroth II gastroenterostomy and Roux-en-Y reconstruction. After successful endoscopy, diagnostic and ERCP success was not achieved in 4 patients with Billroth II gastroenterostomy, with or without Braun anastomosis, due to cannulation failure. The procedure-related complication rate was 5.5% (12/220), including immediate bleeding (0.9%, 2/220), pancreatitis (4.1%, 9/220), and perforation (0.5%, 1/220). There were no procedure-related deaths.
CONCLUSIONS
The side-viewing duodenoscope is a useful instrument for performing successful ERCP in patients postgastrectomy. In addition, retrieval balloon-assisted enterography may improve the enterography success rate in postgastrectomy patients with Billroth II and Roux-en-Y reconstruction.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anastomosis, Roux-en-Y; Child; Cholangiopancreatography, Endoscopic Retrograde; Cholestasis, Extrahepatic; Constriction, Pathologic; Duodenoscopes; Female; Gallstones; Gastrectomy; Gastroenterostomy; Humans; Male; Middle Aged; Retrospective Studies; Treatment Outcome; Young Adult
PubMed: 26535481
DOI: 10.1097/MCG.0000000000000442