Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study.
biliary stone disease
infection
pancreatic cancer
reprocessing
sterile
Journal
Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society
ISSN: 1443-1661
Titre abrégé: Dig Endosc
Pays: Australia
ID NLM: 9101419
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
01
02
2021
accepted:
01
03
2021
pubmed:
6
3
2021
medline:
14
1
2022
entrez:
5
3
2021
Statut:
ppublish
Résumé
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. 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. 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. 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.
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
215-221Informations de copyright
© 2021 Japan Gastroenterological Endoscopy Society.
Références
Dumonceau JM, Delhaye M, Tringali A et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Updated August 2018. Endoscopy 2019; 51: 179-93.
Manes G, Paspatis G, Aabakken L et al. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy 2019; 51: 472-91.
Dumonceau JM, Kapral C, Aabakken L et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-49.
Aumeran C, Poincloux L, Souweine B et al. Multidrug-resistant Klebsiella pneumoniae outbreak after endoscopic retrograde cholangiopancreatography. Endoscopy 2010; 42: 895-9.
Beilenhoff U, Biering H, Blum R et al. 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). Endoscopy 2017; 49: 1098-106.
Ross AS, Bruno MJ, Kozarek RA et al. Novel single-use duodenoscope compared with 3 models of reusable duodenoscopes for ERCP: A randomized bench-model comparison. Gastrointest Endosc 2020; 91: 396-403.
Muthusamy VR, Bruno MJ, Kozarek RA et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2020; 18: 2108-17.
Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. Published online: 7 Sep 2020; DOI: 10.1136/gutjnl-2020-321836.
Cotton PB, Eisen G, Romagnuolo J et al. Grading the complexity of endoscopic procedures: Results of an ASGE working party. Gastrointest Endosc 2011; 73: 868-74.
Holzwanger EA, Bilal M, Saperia J et al. Duodenoscope-related infections and potential role of single-use duodenoscopes. VideoGIE 2020; 5: 628-9.
Bang JY, Rösch T, Kim HM et al. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc 2021; 33: 822-8.
Bilal M, Berzin TM, Cohen J et al. ERCP in patients with COVID-19 infection - Is a single-use duodenoscope the safer option? Endoscopy 2020; 52: 932.