-
JAMA Internal Medicine Mar 2023Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level...
Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.
IMPORTANCE
Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument.
OBJECTIVE
To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.
DESIGN, SETTING, AND PARTICIPANTS
In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible.
INTERVENTION
The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design.
MAIN OUTCOMES AND MEASURES
Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers.
RESULTS
From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes.
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04040504.
Topics: Humans; Female; Middle Aged; Male; Duodenoscopes; Cholangiopancreatography, Endoscopic Retrograde; Elevators and Escalators; Disinfection; Data Collection
PubMed: 36689215
DOI: 10.1001/jamainternmed.2022.6394 -
Revista Espanola de Enfermedades... Apr 2023We present the case of a 67-year-old female with recent cholecystectomy for symptomatic cholelithiasis. She was admitted to our hospital with right upper quadrant...
We present the case of a 67-year-old female with recent cholecystectomy for symptomatic cholelithiasis. She was admitted to our hospital with right upper quadrant abdominal pain and vomiting. Laboratory analysis revealed hyperbilirubinemia with cytolysis and cholestasis. Abdominal ultrasound revealed a choledocholithiasis of 8 mm. Endoscopic retrograde cholangiopancreatography (ERCP) was scheduled. With the duodenoscope, after the reduction maneuver from the second duodenal portion to face the major papilla, a perforation of approximately 18 mm was identified in the contralateral wall distal to it. A gastroscope identified the perforation and a 9.5-11 x 6 mm over-the-scope-clip (OTSC) was placed after inserting its edges into the cap with aspiration (without approximation forceps).
Topics: Female; Humans; Aged; Cholangiopancreatography, Endoscopic Retrograde; Choledocholithiasis; Duodenum; Hospitalization; Iatrogenic Disease
PubMed: 36645071
DOI: 10.17235/reed.2023.9339/2022 -
Infection Control and Hospital... Sep 2023To evaluate variables that affect risk of contamination for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound endoscopes. (Observational Study)
Observational Study
OBJECTIVE
To evaluate variables that affect risk of contamination for endoscopic retrograde cholangiopancreatography and endoscopic ultrasound endoscopes.
DESIGN
Observational, quality improvement study.
SETTING
University medical center with a gastrointestinal endoscopy service performing ∼1,000 endoscopic retrograde cholangiopancreatography and ∼1,000 endoscopic ultrasound endoscope procedures annually.
METHODS
Duodenoscope and linear echoendoscope sampling (from the elevator mechanism and instrument channel) was performed from June 2020 through September 2021. Operational changes during this period included standard reprocessing with high-level disinfection with ethylene oxide gas sterilization (HLD-ETO) was switched to double high-level disinfection (dHLD) (June 16, 2020-July 15, 2020), and duodenoscopes changed to disposable tip model (March 2021). The frequency of contamination for the co-primary outcomes were characterized by calculated risk ratios.
RESULTS
The overall pathogenic contamination rate was 4.72% (6 of 127). Compared to duodenoscopes, linear echoendoscopes had a contamination risk ratio of 3.64 (95% confidence interval [CI], 0.69-19.1). Reprocessing using HLD-ETO was associated with a contamination risk ratio of 0.29 (95% CI, 0.06-1.54). Linear echoendoscopes undergoing dHLD had the highest risk of contamination (2 of 18, 11.1%), and duodenoscopes undergoing HLD-ETO and the lowest risk of contamination (0 of 53, 0%). Duodenoscopes with a disposable tip had a 0% contamination rate (0 of 27).
CONCLUSIONS
We did not detect a significant reduction in endoscope contamination using HLD-ETO versus dHLD reprocessing. Linear echoendoscopes have a risk of contamination similar to that of duodenoscopes. Disposable tips may reduce the risk of duodenoscope contamination.
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Endosonography; Equipment Contamination
PubMed: 36645014
DOI: 10.1017/ice.2022.319 -
Antimicrobial Stewardship & Healthcare... 2022Duodenoscopy-associated infections and outbreaks are reported globally despite strict adherence to duodenoscope reprocessing protocols. Therefore, new developments in...
OBJECTIVE
Duodenoscopy-associated infections and outbreaks are reported globally despite strict adherence to duodenoscope reprocessing protocols. Therefore, new developments in the reprocessing procedure are needed.
DESIGN
We evaluated a novel dynamic flow model for an additional cleaning step between precleaning and manual cleaning in the reprocessing procedure.
METHODS
A parallel plate flow chamber with a fluorinated ethylene propylene bottom plate was used to mimic the duodenoscope channels. The flow chamber was inoculated with a suspension containing to simulate bacterial contamination during a duodenoscopic procedure. After inoculation the flow chamber was flushed with a detergent mimicking precleaning. Subsequently the flow chamber was subjected to different interventions: flow with phosphate-buffered saline (PBS), flow with 2 commercial detergents, flow with sodium dodecyl sulfate with 3 different concentrations, and flow with microbubbles. Adhering bacteria were counted using phase-contrast microscopy throughout the experiment, and finally, bacterial viability was assessed.
RESULTS
During precleaning both PBS and 1% (v/v) Neodisher Mediclean Forte were able to desorb bacteria, but neither proved superior. After precleaning only sodium dodecyl sulfate could desorb bacteria.
CONCLUSIONS
Flushing during precleaning is an essential step for reducing adhering luminal bacteria, and sodium dodecyl sulfate is a promising detergent for bacterial desorption from duodenoscope channels after precleaning.
PubMed: 36483362
DOI: 10.1017/ash.2022.294 -
Turkish Journal of Surgery Jun 2022Endoscopic Retrograde Cholangiopancreatography (ERCP) with conventional side-viewing duodenoscope can be challenging and unsuccessful at altered anatomy in the...
OBJECTIVES
Endoscopic Retrograde Cholangiopancreatography (ERCP) with conventional side-viewing duodenoscope can be challenging and unsuccessful at altered anatomy in the gastrointestinal tract. This study aimed to evaluate our experience with ERCP in patients with previous gastric surgery.
MATERIAL AND METHODS
Patients on whom ERCP was performed from January 2017 to August 2021 and who had previous gastric surgery were included into the study. Age, sex, comorbidity, Charlson's Comorbidity Index (CCI), ERCP indication, previous gastric surgery (indication, type of resection and reconstruction), history of cholecystectomy, and MRCP results were evaluated retrospectively. The results were compared as successful ERCP (SERCP) or unsuccessful ERCP (USERCP). Also, odds ratio ERCP failure was also evaluated.
RESULTS
Forty-three patients were included into study. Mean age was 68.8 ± 13.6 years. The most common sex was female (51.2%). The most common ERCP indication was choledocholithiasis with 44.2%, gastric surgery indication was peptic ulcer with 72.1%, gastric resection was subtotal with 67.4%, and reconstruction was gastrojejunostomy with 58.1%. The success rate of ERCP was 44.2%. Mean CCI was 4.16 ± 2.28. Only malignancy history was significantly higher in the USERCP group (p= 0.026). Male sex, non-choledocholithiasis indication, history of malignancy, CCI> 4, total gastrectomy, Roux-NY (RNY) reconstruction, history of cholecystectomy, and intercalarily to the bile duct dilatation in MRCP were likelihood for USERCP.
CONCLUSION
While history of malignancy and cholecystectomy were the only significant factor for unsuccessful ERCP, male sex, total gastrectomy, RNY anastomosis result in a higher likelihood of ERCP failure in patients with previous gastric surgery. Alternative devices to side-viewing duodenoscope will increase success in selected patients.
PubMed: 36483168
DOI: 10.47717/turkjsurg.2022.5490 -
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 -
DEN Open Apr 2023We report the case of a 62-year-old female with a 6.3-mm low-grade neuroendocrine tumor of the ampulla of Vater, who underwent an endoscopic papillectomy. An endoscopic...
We report the case of a 62-year-old female with a 6.3-mm low-grade neuroendocrine tumor of the ampulla of Vater, who underwent an endoscopic papillectomy. An endoscopic papillectomy was performed without complications. In the 26 months of follow-up, no local recurrence or metastasis occurred. Endoscopic treatment of ampullary neuroendocrine tumors is controversial. However, endoscopic papillectomy may be considered a treatment option if neuroendocrine tumors are small (<10 mm), have a low grade (G1), or do not have muscle layer or bile duct invasion.
PubMed: 36447636
DOI: 10.1002/deo2.191 -
The Journal of Hospital Infection Feb 2023Microbiological cultures are the gold standard in the monitoring of duodenoscope reprocessing. However, many different sampling and culturing techniques are used, making...
AIM
Microbiological cultures are the gold standard in the monitoring of duodenoscope reprocessing. However, many different sampling and culturing techniques are used, making it difficult to compare results. The latest Centers for Disease Control and Prevention protocol advises the use of a neutralizer to deactivate any remaining disinfectants in the samples. This study compared culturing results of duodenoscope samples collected with and without addition of a neutralizer.
METHODS
Six duodenoscopes were soiled with gut bacteria in a non-clinical experimental setting and reprocessed afterwards. Samples of the tip and working channel were collected immediately after decontamination or after drying. Dey-Engley (DE) broth was added as a neutralizer to the samples of four duodenoscopes; samples for the other two duodenoscopes were collected without the addition of DE broth.
RESULTS
Post-decontamination cultures were significantly more likely to be positive for growth of the applied micro-organisms in the group of samples with DE broth (88.1% vs 20.2%; P<0.0001). Post-drying samples were significantly more likely to be positive in the group of samples without DE broth (75.7% vs 33.4%; P<0.001).
CONCLUSION
The addition of DE broth to samples collected from wet duodenoscopes increases the yield of those cultures. Remaining disinfectants in wet duodenoscopes can lead to false-negative results. This can be overcome by adding a neutralizer, such as DE broth, to the samples. The higher yield after drying in the group without neutralizer could be due to biofilm formation in these two duodenoscopes, but this was not investigated. Standardization of the sampling method can help to compare both clinical and study results regarding duodenoscope contamination.
Topics: Humans; Duodenoscopes; Equipment Contamination; Disinfectants; Bacteria; Disinfection
PubMed: 36414167
DOI: 10.1016/j.jhin.2022.11.008 -
Endoscopy International Open Nov 2022Biliary tract emergencies are managed with endoscopic retrograde cholangiopancreatography (ERCP) using duodenoscopes, which are reusable devices that require high-level...
Biliary tract emergencies are managed with endoscopic retrograde cholangiopancreatography (ERCP) using duodenoscopes, which are reusable devices that require high-level disinfection to minimize risk of cross-contamination. Recent reports about newly developed single-use duodenoscopes (SUDs) suggest equivalent performance with reusable duodenoscopes, but the effectiveness of SUDs in emergency ERCP has not yet been studied. We conducted a prospective case series of emergency ERCP procedures using SUDs (EXALT model D-Boston Scientific, United States) in a real-life, tertiary care setting without any possibility of using a back-up reusable duodenoscope. Twenty-one emergent ERCPs (acute cholangitis 48%, severe jaundice 38 %, others 14 %) were performed in 19 patients (mean age 49.5±15 years). Almost all procedures (20 of 21; 95 %) were technically and clinically successful, whereas selective cannulation failed in one case. Among the successful ERCPs, five (24 %) were achieved by a novice operator. The image was often considered skewed toward yellow tones (48 %), whereas stiffness and pushability for stent insertion were found suboptimal in 5 % of the procedures, without any impact on procedure success. SUDs are effective and appropriate devices for emergent situations in real life even in non-expert hands and even if a regular duodenoscope is unavailable as a backup.
PubMed: 36397861
DOI: 10.1055/a-1921-2109 -
Gastroenterology & Hepatology May 2022Recent outbreaks of duodenoscope-associated multidrugresistant organism infections have increased awareness and concern about the pitfalls in high-level disinfection...
Recent outbreaks of duodenoscope-associated multidrugresistant organism infections have increased awareness and concern about the pitfalls in high-level disinfection protocols and duodenoscope design. A call for innovative approaches to reduce the risk of transmission of multidrug-resistant organisms through duodenoscopes has led to the development of single-use duodenoscopes. As a new technology, questions have been raised regarding the performance, safety, cost, feasibility of implementation, and environmental impact of these novel duodenoscopes. This article discusses several of these aspects and presents a brief review of the literature.
PubMed: 36397752
DOI: No ID Found