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Endoscopy Sep 2020A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial...
BACKGROUND
A newly designed duodenoscope with detachable distal cap may reduce bacterial contamination by allowing better access to the elevator. We compared bacterial contamination and organic residue evaluated by rapid adenosine triphosphate (ATP) test and culture from duodenoscopes with detachable vs. fixed distal caps after high-level disinfection (HLD).
METHODS
During December 2018-April 2019, 108 used newly designed duodenoscopes were enrolled. In group A (n = 54), the distal cap of the duodenoscope was detached before manual cleaning. In group B (n = 54), the distal cap was not detached. After HLD, samples were collected from the elevator, submitted for culture, and evaluated using the ATP test, using the cutoff value of 40 relative light units (RLUs).
RESULTS
After HLD, the proportion of potential bacterial contamination and organic residue in group A was significantly lower than in group B (37.0 % vs. 75.9 %; < 0.001; relative risk 0.49, 95 % confidence interval 0.33-0.71), and also confirmed by median ATP values (45.2 vs. 141.0 RLU; < 0.001). In group B, one sample culture was positive for nonpathogenic bacteria. Pathogenic bacteria were not found in any culture from either group.
CONCLUSIONS
The detachable distal cap was more effective at eliminating bacterial contamination and reducing organic residue than a fixed cap. Nonpathogenic bacteria were detected in the fixed cap group after reprocessing. The ATP test with 40 RLU cutoff is a practical method to ensure the cleanliness of duodenoscope reprocessing without the need to wait for bacterial culture results.
Topics: Adenosine Triphosphate; Bacteria; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 32299115
DOI: 10.1055/a-1145-3562 -
Clinical Endoscopy Jan 2022Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminated duodenoscopes. In 2015, the United States Food and Drug...
BACKGROUND/AIMS
Multiple outbreaks of multidrug-resistant organisms have been reported worldwide due to contaminated duodenoscopes. In 2015, the United States Food and Drug Administration recommended the following supplemental enhanced surveillance and reprocessing techniques (ESRT) to improve duodenoscope disinfection: (1) microbiological culture, (2) ethylene oxide sterilization, (3) liquid chemical sterilant processing system, and (4) double high-level disinfection. A systematic review and meta-analysis was performed to assess the impact of ESRT on the contamination rates.
METHODS
A thorough and systematic search was performed across several databases and conference proceedings from inception until January 2021, and all studies reporting the effectiveness of various ESRTs were identified. The pooled contamination rates of post-ESRT duodenoscopes were estimated using the random effects model.
RESULTS
A total of seven studies using various ESRTs were incorporated in the analysis, which included a total of 9,084 post-ESRT duodenoscope cultures. The pooled contamination rate of the post-ESRT duodenoscope was 5% (95% confidence interval [CI]: 2.3%-10.8%, inconsistency index [I2]=97.97%). Pooled contamination rates for high-risk organisms were 0.8% (95% CI: 0.2%-2.7%, I2=94.96).
CONCLUSION
While ESRT may improve the disinfection process, a post-ESRT contamination rate of 5% is not negligible. Ongoing efforts to mitigate the rate of contamination by improving disinfection techniques and innovations in duodenoscope design to improve safety are warranted.
PubMed: 34974676
DOI: 10.5946/ce.2021.212 -
World Journal of Gastrointestinal... Aug 2014Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy is challenging. Several operative interventions of both the... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy is challenging. Several operative interventions of both the gastrointestinal tract and the biliary and/or pancreatic system lead to altered anatomy, rendering ERCP more difficult or even impossible with a conventional side-viewing duodenoscope. Adapted endoscopes are available to reach the biliopancreatic system and to perform ERCP in patients with altered anatomy. However, both technical difficulties and complications determine the procedure's success. Different technical approaches have been described and are highly dependent on local expertise and endoscopic equipment. Standardized practical guidelines are currently unavailable. This review focuses on the challenges encountered during ERCP in patients with altered anatomy and how to deal with them. The first challenge is reaching the papilla or the bilioenteric/pancreatoenteric anastomosis in the patient with postoperative altered anatomy. The second challenge is the cannulation of the biliopancreatic system and performing all conventional ERCP interventions and the third challenge is the control of possible complications. The available literature data on this topic is reviewed and illustrated with clinical cases.
PubMed: 25132917
DOI: 10.4253/wjge.v6.i8.345 -
Internal Medicine (Tokyo, Japan) Jul 2021Objective It is difficult to insert a side-viewing duodenoscope during endoscopic retrograde cholangiopancreatography in patients with esophagogastroduodenal...
Objective It is difficult to insert a side-viewing duodenoscope during endoscopic retrograde cholangiopancreatography in patients with esophagogastroduodenal deformities. To evaluate the efficacy and safety of using a large balloon anchor technique for cases in which inserting side-viewing duodenoscopes is difficult. Methods We retrospectively examined patients with endoscopic retrograde cholangiopancreatography who required the large balloon anchor technique between April 2016 and October 2020. Patients with deformed superior duodenal angles, esophagogastric junctions and pyloric rings and those having a shortened lesser curve were included. Results The balloon as an anchor was safely used to insert the duodenoscopes in 17 patients, and this procedure was performed 21 times. The procedure was successful 20 out of 21 times (95.2%), including 12 cases with duodenal deformities, 5 with shortening of the lesser curve, 2 after duodenal stent placement and 1 with a deformity of the esophagogastric junction. In the remaining patient, the first ERCP was successful, but the second was unsuccessful with duodenal deformities. There were no complications throughout the course of the study. Conclusion The large balloon anchor technique is a safe and useful technique for patients when inserting side-viewing duodenoscopes is difficult for various reasons.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Humans; Retrospective Studies; Stents; Treatment Outcome
PubMed: 33612682
DOI: 10.2169/internalmedicine.6624-20 -
Clinical Endoscopy May 2020Endoscopic retrograde cholangiopancreatography (ERCP) requires a unique skill set. Currently, there is no objective methodology to assess and train a professional to...
BACKGROUND/AIMS
Endoscopic retrograde cholangiopancreatography (ERCP) requires a unique skill set. Currently, there is no objective methodology to assess and train a professional to perform ERCP. This study aimed to develop and validate a novel ERCP simulator.
METHODS
The simulator consists of papillae presenting different anatomy and positioned in varied locations. Deep cannulation of the pancreatic duct, followed by the bile duct, was performed. The time allotted was 5 minutes. The content validity indexes (CVIs) for realism, relevance, and representativeness were calculated. Correlation between ERCP experience and simulator score was determined.
RESULTS
Twenty-three participants completed the simulation. The CVIs for realism were orientation of duodenoscope to papilla (1.00), angulation of papillotome to achieve cannulation (0.71), and haptic feedback during cannulation (0.80). The CVIs for relevance were use of elevator (1.00), wheels to achieve en face orientation (1.00), and papillotome for selective cannulation (1.00). Regarding CVI for representativeness, the results were as follows: basic cannulation (0.83), papilla locations (0.83), and papilla anatomies (0.80). The novice, intermediate, and experienced groups scored 6.7±8.7, 30.0±16.3, and 74.4±43.9, respectively (p<0.0001). There was a strong correlation between the ERCP experience level and the individual's simulator score (Pearson value of 0.77, R2 of 0.60).
CONCLUSION
This simulator appears to be realistic, relevant, and representative of ERCP cannulation techniques. Additionally, it is effective at objectively assessing basic ERCP skills by differentiating scores based on clinical experience.
PubMed: 32062958
DOI: 10.5946/ce.2019.105 -
Scientific Reports Dec 2023Endoscopy training models (ETM) using artificial organs are practical, hygienic and comfortable for trainees. However, few models exist for training endoscopic...
Endoscopy training models (ETM) using artificial organs are practical, hygienic and comfortable for trainees. However, few models exist for training endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy. This training is necessary as the number of bariatric surgeries performed worldwide increases. ETM with human-like anatomy were developed to represent the postoperative anatomy after Billroth II (BII) reconstruction for a standard duodenoscope and the situs of a long-limbed Roux-en-Y (RY) for device-assisted enteroscopy (DAE). In three independent workshops, the models were evaluated by international ERCP experts. In RY model, a simulation for small bowel behavior in endoscopy was created. Thirty-three experts rated the ETM in ERCP expert courses. The BII model was evaluated as suitable for training (school grades 1.36), with a haptic and visual impression rating of 1.73. The RY model was rated 1.50 for training suitability and 2.06 for overall impression. Animal tissue-free ETMs for ERCP in surgically altered anatomy were successfully created. Evaluation by experienced endoscopists indicated that the models are suitable for hands-on ERCP training, including device-assisted endoscopy. It is expected that patient care will improve with appropriate training in advanced procedures.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Intestine, Small; Endoscopy, Gastrointestinal; Anastomosis, Roux-en-Y; Artificial Organs; Retrospective Studies
PubMed: 38129520
DOI: 10.1038/s41598-023-49888-3 -
Digestive Endoscopy : Official Journal... Jul 2021While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively... (Observational Study)
Observational Study
OBJECTIVE
While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes.
METHODS
An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool.
RESULTS
The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores.
CONCLUSIONS
The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Humans; Prospective Studies; Reproducibility of Results
PubMed: 33007136
DOI: 10.1111/den.13856 -
Endoscopy Nov 2017Patients should be informed about the benefits and risks of endoscopic retrograde cholangiopancreatography (ERCP)Only specially trained and competent personnel should... (Review)
Review
Prevention of multidrug-resistant infections from contaminated duodenoscopes: Position Statement of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology Nurses and Associates (ESGENA).
Patients should be informed about the benefits and risks of endoscopic retrograde cholangiopancreatography (ERCP)Only specially trained and competent personnel should carry out endoscope reprocessing.Manufacturers of duodenoscopes should provide detailed instructions on how to use and reprocess their equipment.In the case of modifications to their equipment, manufacturers should provide updated instructions for use.Detailed reprocessing protocols based on the manufacturer's instructions for use should clearly lay out the different reprocessing steps necessary for each endoscope model.Appropriate cleaning equipment should be used for duodenoscopes in compliance with the manufacturer's instructions for use. Only purpose-designed, endoscope type-specific, single-use cleaning brushes should be used, to ensure optimal cleaning. As soon as the endoscope is withdrawn from the patient, bedside cleaning should be performed, followed by leak testing, thorough manual cleaning steps, and automated reprocessing, in order to: · Remove debris from external and internal surfaces;. · Prevent any drying of body fluids, blood, or debris;. · Prevent any formation of biofilms.. In addition to the leak test, visual inspection of the distal end as well as regular maintenance of duodenoscopes should be performed according to the manufacturer's instructions for use, in order to detect any damage at an early stage.The entire reprocessing procedure in endoscope washer-disinfectors (EWDs) should be validated according to the European and International Standard, EN ISO 15883. Routine technical tests of EWDs should be performed according to the validation reports.Microbiological surveillance of a proportion of the department's endoscopes should be performed every 3 months, with the requirement that all endoscopes used in the unit are tested at least once a year.In the case of suspected endoscopy-related infection, the relevant device (e. g., endoscope, EWD) should be taken out of service until adequate corrective actions have been taken. Outbreaks should be managed by a multidisciplinary team, including endoscopy, hygiene, and microbiology experts, manufacturers, and regulatory bodies, according to national standards and/or laws. In the case of suspected multidrug-resistant organism (MDRO) outbreaks, close cooperation between the endoscopy unit and the clinical health provider is essential (including infection control departments and hospital hygienists).
Topics: Cross Infection; Decontamination; Drug Resistance, Multiple; Duodenoscopes; Equipment Contamination; Humans; Infection Control
PubMed: 29036747
DOI: 10.1055/s-0043-120523 -
Endoscopy Jun 2018Duodenoscopes have been the source of serious infection, despite correct performance of high-level disinfection (HLD). This study aimed to observe the impact of...
BACKGROUND AND STUDY AIM
Duodenoscopes have been the source of serious infection, despite correct performance of high-level disinfection (HLD). This study aimed to observe the impact of performing HLD twice on the rate of positive cultures from duodenoscope elevators.
METHODS
We performed double HLD (DHLD; i. e. complete manual cleaning followed by automated reprocessing, with the entire process repeated) and then randomly cultured the elevators of our duodenoscopes on about 30 % of occasions.
RESULTS
DHLD was associated with positive elevator cultures for any microorganism in 9.4 % of cases, with a 0.8 % rate of known pathogens (627 cultures) between May 2015 and February 2016. After February 2016, and in association with changing the precleaning fluid, as well as use of a new FDA-recommended cleaning brush, the rate of positive cultures for any microorganism after DHLD was 4.8 % and 0.2 % for known pathogens (420 cultures). In a third phase, characterized by a change in personnel performing DHLD and retirement of a duodenoscope with a high rate of positive cultures, the rate of positive cultures for any microorganism was 4.9 % (783 cultures) and the rate of positive culture for known pathogens was 0.3 %. To our knowledge, no duodenoscope transmission of infection occurred during the study interval.
CONCLUSIONS
DHLD resulted in a low rate of positive cultures for known pathogens and for organisms of low pathogenic potential, but did not eliminate these, from duodenoscope elevators. Additional improvements in HLD protocols and/or duodenoscope design are needed.
Topics: Bacillus; Candida glabrata; Cholangiopancreatography, Endoscopic Retrograde; Disinfectants; Disinfection; Duodenoscopes; Enterococcus; Equipment Contamination; Equipment Reuse; Micrococcus; Staphylococcus
PubMed: 29237202
DOI: 10.1055/s-0043-122378 -
Translational Pediatrics Oct 2021The indications for endoscopic retrograde cholangiopancreatography (ERCP) in infant patients (age <1 year) differ from those in adults. A paucity of data and concerns...
BACKGROUND
The indications for endoscopic retrograde cholangiopancreatography (ERCP) in infant patients (age <1 year) differ from those in adults. A paucity of data and concerns about the potential lower effectiveness and more adverse effects limit its utility, even in tertiary care centres. In this study, we retrospectively analysed the indications, success rates, and adverse effects of ERCP in these groups.
METHODS
From June 2014 to March 2018, 17 ERCPs were performed in 15 children [median age: 10.4 months (6-12 months); median weight: 6.6 kg (3.3-10.7 kg)]. A conventional duodenoscope was utilized in all procedures. All patients were followed up as inpatients.
RESULTS
Fifteen therapeutic and two diagnostic procedures were managed by licensed paediatric endoscopist. Successful cannulation was obtained in all patients (100%). A high proportion (47.1%) of pancreaticobiliary maljunction (PBM) and therapeutic procedures (88.2%) were identified. Two cases of mild pancreatitis were recorded, accounting for 12.5% of the post-ERCP pancreatitis (PEP) rate. By multivariable analysis, recurrent acute pancreatitis and pancreatic duct (PD) cannulation/injection were identified as PEP-related risk factors. All complications were managed conservatively.
CONCLUSIONS
ERCP in infant patients (0.5< age <1 year) could be safely completed by conservational endoscopy. A high proportion of PBM and therapeutic procedures were identified in our study cohort. The overall adverse-event rate was acceptable, and no serious complication occurred. The PEP-related independent risk factors included recurrent acute pancreatitis and PD cannulation/injection.
PubMed: 34765474
DOI: 10.21037/tp-21-406