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Gastrointestinal Endoscopy Oct 2021Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus...
BACKGROUND AND AIMS
Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process.
METHODS
Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement.
RESULTS
Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%).
CONCLUSIONS
This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Consensus; Delphi Technique; Endoscopy; Humans; Treatment Outcome
PubMed: 33887269
DOI: 10.1016/j.gie.2021.04.009 -
World Journal of Gastroenterology Jul 2019Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy must be performed by a highly experienced endoscopist. The challenges... (Review)
Review
Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy must be performed by a highly experienced endoscopist. The challenges are accessing the afferent limb in different types of reconstruction, cannulating a papilla with a reverse orientation, and performing therapeutic interventions with uncommon endoscopic accessories. The development of endoscopic techniques has led to higher success rates in this group of patients. Device-assisted ERCP is the endoscopic procedure of choice for high success rates in short-limb reconstruction; however, these success rate is lower in long-limb reconstruction. ERCP assisted by endoscopic ultrasonography is now popular because it can be performed independent of the limb length; however, it must be performed by a highly experienced and skilled endoscopist. Stent deployment and small stone removal can be performed immediately after ERCP assisted by endoscopic ultrasonography, but the second session is needed for other difficult procedures such as cholangioscopy-guided electrohydraulic lithotripsy. Laparoscopic-assisted ERCP has an almost 100% success rate in long-limb reconstruction because of the use of a conventional side-view duodenoscope, which is compatible with standard accessories. This requires cooperation between the surgeon and endoscopist and is suitable in urgent situations requiring concomitant cholecystectomy. This review focuses on the advantages, disadvantages, and outcomes of various procedures that are suitable in different situations and reconstruction types. Emerging new techniques and their outcomes are also discussed.
Topics: Biliary Tract; Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy; Duodenoscopes; Endosonography; Gastrectomy; Gastric Bypass; Humans; Laparoscopy; Pancreaticoduodenectomy; Plastic Surgery Procedures; Stents; Treatment Outcome; Ultrasonography, Interventional
PubMed: 31341358
DOI: 10.3748/wjg.v25.i26.3313 -
Gastrointestinal Endoscopy Jun 2020Outbreaks of infections transmitted by duodenoscopes have prompted changes to duodenoscope cleaning protocols. However, little is known about effectiveness of clinical...
BACKGROUND AND AIMS
Outbreaks of infections transmitted by duodenoscopes have prompted changes to duodenoscope cleaning protocols. However, little is known about effectiveness of clinical cleaning practices. We present culture data after duodenoscope manufacturer-recommended high-level disinfection (HLD) and quarantine.
METHODS
Our institution adopted a combination of manufacturer-recommended cleaning with the Centers for Disease Control and Prevention-recommended culture and quarantine in 2015. Duodenoscopes (models TJF-Q180V, TJF-160, and PJF-160; Olympus, Center Valley, Penn, USA) underwent HLD according to the manufacturer's reprocessing manual protocols after use. Two culture specimens were then obtained using a sterile brush from the distal tip, including elevator mechanism, and by flushing sterile water through the working channel. Duodenoscopes were quarantined until cultures resulted. Positive cultures were defined as >10 colony-forming units (CFUs) of low-concern organisms or any CFUs of high-concern organisms according to Centers for Disease Control and Prevention recommendations. If either culture specimen was positive, the process was repeated until cultures were negative. Data were collected from December 2015 to July 2018.
RESULTS
There were 140 instances of duodenoscope cleaning with 280 specimens. Twenty-eight of 234 (12%) initial culture specimens (18% of cultured duodenoscopes) were positive. Five of 36 (14%) second cultures were positive. Two of 8 (25%) third cultures were positive. Ninety-eight percent of organisms cultured were gram positive. In 8 instances both culture methods (brushing and flush) were positive; otherwise, only 1 method was positive. In 11 instances (8%) duodenoscopes were removed from quarantine before final culture results. No patient had infections related to ERCP.
CONCLUSIONS
Eighteen percent of duodenoscopes had a positive culture after initial HLD. Only 3% were gram-negative bacteria. Repeated HLD was 86% and 75% effective at eliminating initial and repeat positive cultures, respectively. Initial HLD per manufacturer recommendations is not always effective at eliminating bacterial contamination. Additional steps are necessary to decrease risks of duodenoscope-transmitted infections.
Topics: Disease Outbreaks; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Quarantine
PubMed: 31945325
DOI: 10.1016/j.gie.2019.12.050 -
Persistent contamination of a duodenoscope working channel in a non-clinical simulated ERCP setting.Endoscopy Nov 2022To mitigate duodenoscope contamination, recent design enhancements have primarily focused on the distal tip. However, the working channels remain unchanged, which may be...
BACKGROUND
To mitigate duodenoscope contamination, recent design enhancements have primarily focused on the distal tip. However, the working channels remain unchanged, which may be linked to biofilm formation. We assessed the persistence of microorganisms, indicative of biofilm formation, in reprocessed duodenoscopes in a non-clinical endoscopic retrograde cholangiopancreatography (ERCP) simulation setting.
METHODS
Three new duodenoscopes were over-soiled in non-clinical ERCP simulations followed by reprocessing. After 40 tests, the strain in the soil (Pa-type 1) was switched to a different strain (Pa-type 2) for 20 subsequent tests. Cultures of the tip and working channel were acquired after high level disinfection and overnight storage.
RESULTS
One duodenoscope showed persistent growth of from the fifth test until the end of the study. Pa-type 1 remained present until the end of the study in the cultures of this duodenoscope, even after discontinuation of exposure to that specific strain. The other two duodenoscopes only showed incidental contamination.
CONCLUSION
Persistent contamination by Pa-type 1 was seen in one out of three duodenoscopes after exposure to supraphysiological levels of gut microorganisms. No clear explanation was found for this persistent contamination as exposure and handling were identical and no abnormalities of this particular duodenoscope were identified by borescope inspection.
Topics: Humans; Duodenoscopes; Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Equipment Contamination
PubMed: 35512820
DOI: 10.1055/a-1814-4379 -
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 -
Digestive Endoscopy : Official Journal... Jan 2022A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The...
OBJECTIVES
A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study.
METHODS
All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis.
RESULTS
Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related.
CONCLUSIONS
The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.
Topics: Aged; Bile Duct Diseases; Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Duodenoscopes; Female; Humans; Prospective Studies
PubMed: 33666280
DOI: 10.1111/den.13965 -
Gastroenterology Jan 2021
Topics: Aged, 80 and over; Arytenoid Cartilage; Cholangiopancreatography, Endoscopic Retrograde; Duodenoscopes; Hoarseness; Humans; Male; Postoperative Complications
PubMed: 32511973
DOI: 10.1053/j.gastro.2020.05.071 -
Gastrointestinal Endoscopy May 2021Multidrug-resistant infectious outbreaks associated with duodenoscopes have been documented internationally. Single-use duodenoscopes, disposable distal ends, or distal...
BACKGROUND AND AIMS
Multidrug-resistant infectious outbreaks associated with duodenoscopes have been documented internationally. Single-use duodenoscopes, disposable distal ends, or distal end cap sealants could eliminate or reduce exogenous patient-to-patient infection associated with ERCP.
METHODS
This document reviews technologies that have been developed to help reduce or eliminate exogenous infections because of duodenoscopes.
RESULTS
Four duodenoscopes with disposable end caps, 1 end sheath, and 2 disposable duodenoscopes are reviewed in this document. The evidence regarding their efficacy in procedural success rates, reduction of duodenoscope bacterial contamination, clinical outcomes associated with these devices, safety, and the financial considerations are discussed.
CONCLUSIONS
Several technologies discussed in this document are anticipated to eliminate or reduce exogenous infections during endoscopy requiring a duodenoscope. Although disposable duodenoscopes can eliminate exogenous ERCP-related risk of infection, data regarding effectiveness are needed outside of expert centers. Additionally, with more widespread adoption of these new technologies, more data regarding functionality, medical economics, and environmental impact will accrue. Disposable distal end caps facilitate duodenoscope reprocessing; postmarketing surveillance culture studies and real-life patient infection analyses are important areas of future research.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Cross Infection; Disease Outbreaks; Disinfection; Duodenoscopes; Equipment Contamination; Humans
PubMed: 33712228
DOI: 10.1016/j.gie.2020.12.033 -
Expert Review of Medical Devices May 2021: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial... (Review)
Review
: The management of pancreaticobiliary disorders relies heavily on endoscopic retrograde cholangiopancreatography, which is performed with a duodenoscope. Bacterial colonization of reusable duodenoscopes leading to subsequent infectious outbreaks is well recognized and remains an issue despite efforts to optimize best practices in high-level disinfection. The EXALT Model D duodenoscope (EXALT) (Boston Scientific Corporation, Marlborough, MA) is a single-use device, designed to achieve technical equivalency with reusable devices while eliminating the potential for device-related outbreaks.: This review covers the challenges associated with reprocessing duodenoscopes and the development of duodenoscope-related infections, with an emphasis on the use of single-use duodenoscopes as a potential solution to this issue.: Duodenoscope-related infections are an increasingly recognized problem. Infectious outbreaks harm patients, significantly affect providers and medical centers, and can erode patient trust in the health-care system. Single-use duodenoscopes eliminate both the risk of device-related infection transmission and the need for burdensome duodenoscope reprocessing. In clinical evaluations, the EXALT device has demonstrated an equivalent technical performance and provider satisfaction compared to reusable duodenoscopes. Increasing use of this device will clarify how it compares to reusable duodenoscopes in a variety of clinical settings among endoscopists of varying skills levels.
Topics: Cholangiopancreatography, Endoscopic Retrograde; Disinfection; Duodenoscopes; Equipment Contamination; Humans; Product Surveillance, Postmarketing; Social Control, Formal
PubMed: 33855920
DOI: 10.1080/17434440.2021.1917990 -
Journal of Hepato-biliary-pancreatic... Mar 2023A peroral cholangioscope (POCS) can allow direct visualization of the biliary mucosa and its use is becoming more widespread due to improvements in functionality, image...
BACKGROUND/PURPOSE
A peroral cholangioscope (POCS) can allow direct visualization of the biliary mucosa and its use is becoming more widespread due to improvements in functionality, image quality, and operability, as well as the development of related devices. Recently, a novel mother-baby peroral cholangioscope (nMB-POCS) with a large (2-mm) accessory channel has been developed. In this study, we evaluated the feasibility of this novel POCS in a dry simulation and animal model.
METHODS
We evaluated the ease of insertion and maneuverability of the nMB-POCS, the image quality, and the passage of the devices into the accessory channel and into the common bile duct in a dry and live porcine model.
RESULTS
In both models, the nMB-POCS could be easily inserted into the duodenoscope and into the distal bile duct and hilum. The image quality was good, and it was possible to observe the surface structure and the vascular network of the bile duct mucosa in detail.
CONCLUSIONS
The nMB-POCS with its larger accessory channel is expected to improve the efficiency of diagnosis and treatment, and reduce the procedure time. Clinical studies in patients are warranted.
Topics: Animals; Swine; Cholangiopancreatography, Endoscopic Retrograde; Bile Ducts; Laparoscopy; Biliary Tract Surgical Procedures; Common Bile Duct
PubMed: 36043228
DOI: 10.1002/jhbp.1231