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Endoscopy Oct 2023BACKGROUND : Outbreaks of multidrug-resistant bacteria due to contaminated duodenoscopes and infection risks during the COVID-19 pandemic have driven the development...
BACKGROUND : Outbreaks of multidrug-resistant bacteria due to contaminated duodenoscopes and infection risks during the COVID-19 pandemic have driven the development of single-use endoscopes. The first single-use gastroscope is now available in Europe. Besides waste disposal and cost issues, the infection risk and performance remain unclear. We aimed to evaluate a single-use gastroscope in patients with signs of upper gastrointestinal bleeding. METHODS : 20 consecutive patients presenting with clinical signs of upper gastrointestinal bleeding between October and November 2022 were included in this case series. The primary aim was technical success, defined as access to the descending duodenum and adequate assessment of the upper gastrointestinal tract for the presence of a bleeding site. RESULTS : The primary aim was achieved in 19/20 patients (95 %). The bleeding site was identified in 18 patients. A therapeutic intervention was performed in six patients (two cap-mounted clips, one standard hemostatic clip, two variceal band ligations, one hemostatic powder, two adrenaline injections); technical and clinical success were achieved in all six patients. Two crossovers to a standard gastroscope occurred. CONCLUSIONS : Use of single-use gastroscopes may be feasible for patients presenting for urgent endoscopic evaluation and treatment of upper gastrointestinal bleeding.
Topics: Humans; Gastroscopes; Feasibility Studies; Pandemics; Treatment Outcome; COVID-19; Gastrointestinal Hemorrhage; Hemostatics; Hemostasis, Endoscopic
PubMed: 37160261
DOI: 10.1055/a-2089-5969 -
Clinical Endoscopy Jan 2024Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in...
BACKGROUND/AIMS
Selective bile duct or pancreatic duct cannulation remains a significant initial hurdle in endoscopic retrograde cholangiopancreatography (ERCP) despite advances in endoscopy and accessories. This study evaluated our experience with a rotatable sphincterotome in cases of difficult cannulation.
METHODS
We retrospectively reviewed ERCP cases using TRUEtome, a rotatable sphincterotome, as a rescue device for cannulation at a cancer institute in Japan from October 2014 to December 2021.
RESULTS
TRUEtome was used in 88 patients. Duodenoscopes were used for 51 patients, while single-balloon enteroscopes (SBE) were used for 37 patients. TRUEtome was used for biliary and pancreatic duct cannulation (84.1%), intrahepatic bile duct selection (12.5%), and strictures of the afferent limb (3.4%). Cannulation success rates were similar in the duodenoscope and SBE groups (86.3% vs. 75.7%, p=0.213). TRUEtome was more commonly used in cases with steep cannulation angles in the duodenoscope group and in cases requiring cannulation in different directions in the SBE group. There were no significant differences in adverse events between the two groups.
CONCLUSION
The cannulation sphincterotome was useful for difficult cannulations in both unaltered and surgically altered anatomies. It may be an option to consider before high-risk procedures such as precut and endoscopic ultrasound-guided rendezvous techniques.
PubMed: 37157962
DOI: 10.5946/ce.2022.248 -
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 -
Digestive and Liver Disease : Official... Jan 2024Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary... (Meta-Analysis)
Meta-Analysis Review
Cannulation rates and technical performance evaluation of commericially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis.
BACKGROUND
Single use duodenoscopes were developed to reduce the risk of infection transmission from contaminated reusable duodenoscopes. To this end, we examined various biliary interventions using single use duodenoscopes in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP).
METHODS
Medline, Embase, Scopus, and Cochrane databases were searched from inception through Aug 2022 to identify studies reporting on the performance of single use duodenoscopes for ERCP.
RESULTS
Seven articles were included in the final analysis that included 642 patients (318 males). The Exalt Model D duodenoscope was used in most cases (88.8%) followed by the aScope Duodeno (11.2%) for ERCP. Most ERCPs had a complexity grade of 2 (n = 303) and 3 (n = 198). The pooled cumulative rate of successful cannulation was 95% (95% Confidence Interval (CI): 93-96%, I2=0%, P = 0.46). Sphincterotomy was successfully performed in all cases. The pooled cumulative rate of PEP was 2% (95% CI: 0.4-3.4%, I2=0%, P = 0.80). The pooled cumulative rate of total adverse events was 7% (95% CI: 4-10%, I2=47%, P = 0.08).
CONCLUSIONS
The results of this systematic review and meta-analysis show that single use duodenoscopes are associated with high cannulation rates, technical performance, and safety profile.
Topics: Male; Humans; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Catheterization
PubMed: 37003844
DOI: 10.1016/j.dld.2023.02.022 -
Gastroenterology Sep 2023
Topics: Humans; Cholangiopancreatography, Endoscopic Retrograde; Elevators and Escalators; Disposable Equipment; Duodenoscopes; Equipment Contamination
PubMed: 36940776
DOI: 10.1053/j.gastro.2023.03.209 -
Digestive Endoscopy : Official Journal... Nov 2023Little is known about how to perform the endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) in patients with... (Observational Study)
Observational Study
Risk factors of anastomosis-related difficult endoscopic retrograde cholangiopancreatography following endoscopic ultrasound-guided gastro-gastrostomy using a standardized protocol (with video).
OBJECTIVES
Little is known about how to perform the endoscopic ultrasound (EUS)-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) in patients with gastric bypass using lumen-apposing metal stents (LAMS). The aim was to assess the risk factors of anastomosis-related difficult ERCP.
METHODS
Observational single-center study. All patients who underwent an EDGE procedure in 2020-2022 following a standardized protocol were included. Risk factors for difficult ERCP, defined as the need of >5 min LAMS dilation or failure to pass a duodenoscope in the second duodenum, were assessed.
RESULTS
Forty-five ERCPs were performed in 31 patients (57.4 ± 8.2 years old, 38.7% male). The EUS procedure was done using a wire-guided technique (n = 28, 90.3%) for biliary stones (n = 22, 71%) in most cases. The location of the anastomosis was gastro-gastric (n = 24, 77.4%) and mainly in the middle-excluded stomach (n = 21, 67.7%) with an oblique axis (n = 22, 71%). The ERCP technical success was 96.8%. There were 10 difficult ERCPs (32.3%) due to timing (n = 8), anastomotic dilation (n = 8), or failure to pass (n = 3). By multivariable analysis adjusted by two-stage procedures, the risk factors for a difficult ERCP were the jejuno-gastric route (85.7% vs. 16.7%; odds ratio [OR ] 31.875; 95% confidence interval [CI] 1.649-616.155; P = 0.022), and the anastomosis to the proximal/distal excluded stomach (70% vs. 14.3%; OR 22.667; 95% CI 1.676-306.570; P = 0.019). There was only one complication (3.2%) and one persistent gastro-gastric fistula (3.2%) in a median follow-up of 4 months (2-18 months), with no weight regain (P = 0.465).
CONCLUSIONS
The jejunogastric route and the anastomosis with the proximal/distal excluded stomach during the EDGE procedure increase the difficulty of ERCP.
Topics: Aged; Female; Humans; Male; Middle Aged; Cholangiopancreatography, Endoscopic Retrograde; Endosonography; Gastric Bypass; Gastrostomy; Observational Studies as Topic; Retrospective Studies; Risk Factors; Stents; Ultrasonography, Interventional
PubMed: 36872440
DOI: 10.1111/den.14544 -
Infection Control and Hospital... Oct 2023We report 2 outbreaks of genetically unrelated carbapenem-resistant New Delhi metallo-β-lactamase-producing caused by contaminated duodenoscopes. Using endoscopes with...
We report 2 outbreaks of genetically unrelated carbapenem-resistant New Delhi metallo-β-lactamase-producing caused by contaminated duodenoscopes. Using endoscopes with disposable end caps, adherence to the manufacturer's reprocessing instructions, routine audits, and manufacturer evaluation are critical in preventing such outbreaks.
Topics: Humans; Escherichia coli; beta-Lactamases; Carbapenem-Resistant Enterobacteriaceae; Duodenoscopes; Disease Outbreaks; Carbapenems; Microbial Sensitivity Tests; Anti-Bacterial Agents
PubMed: 36815278
DOI: 10.1017/ice.2023.21 -
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 -
Journal of Clinical Gastroenterology Sep 2023Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the...
INTRODUCTION
Single-use disposable duodenoscopes (SDD) have been developed to mitigate infectious risks related to reusable duodenoscopes. The aim of this study is to compare the safety and efficacy of the two available SDDs in the United States.
METHODS
We conducted a comparative study of 2 SDD in consecutive ERCP procedures performed by expert endoscopists from 9 academic centers. Performance ratings, procedure details, and adverse events were collected.
RESULTS
A total of 201 patients were included: 129 patients underwent ERCP with Exalt (mean age 63, Males- 66 (51%), 72 with aScope Duodeno (mean age 65, males=30 (42%). A majority of endoscopists had performed >2000 ERCPs in both groups (71% Exalt, 93% aScope Duodeno). Technical success was 92% in both groups (n=119 Exalt-group, n=66 aScope-Duodeno-group). The procedural complexity for the ERCP cases performed were: Grade 1: 35 cases (18%), Grade 2: 83 cases (41%), Grade 3: 65 cases (32%), and Grade 4: 18 cases (9%). Thirteen patients (10%) from the Exalt group and 16 patients (22%) from the aScope Duodeno group required conversion to a reusable duodenoscope. On a scale of 1 to 5, Exalt and aScope Duodeno, respectively, were rated: 2.31 versus 2.60 for location and visualization quality, 1.38 versus 1.57 for maneuverability based on papillary orientation, 1.48 versus 1.15 for suction/air control, and 2.31 versus 2.34 for elevator efficiency. None of the adverse events were related to the SDDs.
CONCLUSIONS
The 2 SDDs were comparable. Further ongoing enhancements to these devices will improve maneuverability and clinical effectiveness.
Topics: Male; Humans; Middle Aged; Aged; Duodenoscopes; Cholangiopancreatography, Endoscopic Retrograde
PubMed: 35997700
DOI: 10.1097/MCG.0000000000001752 -
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