Urgent ERCP performed with single-use duodenoscope (SUD) in patients with moderate-to-severe cholangitis: Single-center prospective study

Abstract

Background and study aims To assess the outcomes of urgent endoscopic retrograde cholangiopancreatography (ERCP) performed with a single-use duodenoscope (SUD) in patients with moderate-to-severe cholangitis.

Patients and methods Between 2021 and 2022 consecutive patients with moderate-to-severe cholangitis were prospectively enrolled to undergo urgent ERCP with SUD. Technical success was defined as the completion of the planned procedure with SUD. Multivariate analysis was used to identify factors related to incidence of adverse events (AEs) and mortality.

Results Thirty-five consecutive patients (15 female, age 81.4±6.7 years) were enrolled. Twelve (34.3%) had severe cholangitis; 26 (74.3%) had an American Society of Anesthesiologists (ASA) score ≥3. Twenty-eight patients (80.0%) had a naïve papilla. Biliary sphincterotomy and complete stone clearance were performed in 29 (82.9%) and 30 patients (85.7%), respectively; in three cases (8.6%), concomitant endoscopic ultrasound-gallbladder drainage was performed. Technical and clinical success rates were 100%. Thirty-day and 3-month mortality were 2.9% and 14.3%, respectively. One patient had mild post-ERCP pancreatitis and two had delayed bleeding. No patient or procedural variables were related to AEs. ASA score 4 and leucopenia were related to 3-month mortality; on multivariate analysis, leukopenia was the only variable independently related to 3-month mortality (odds ratio 12.8; 95% confidence interval 1.03–157.2; P=0.03).

Conclusions The results of this “proof of concept” study suggest that SUD use could be considered safe and effective for urgent ERCP for acute cholangitis. This approach abolishes duodenoscope contamination from infected patients without impairing clinical outcomes.

Keywords

Stones - Cholangioscopy - Quality and logistical aspects - Hygiene

Publication History

Received: 25 August 2023

Accepted after revision: 10 November 2023

Accepted Manuscript online:
28 November 2023

Article published online:
19 January 2024

• References

• 1 Boxhoorn L, Voermans RP, Bouwense SA. et al. Acute pancreatitis. Lancet 2020; 396: 726-734 DOI: 10.1016/S0140-6736(20)31310-6. (PMID: 32891214)
• 2 Williams E, Beckingham I, El Sayed G. et al. Updated guideline on the management of common bile duct stones (CBDS). Gut 2017; 66: 765-782
• 3 Dumonceau JM, Kapral C, Aabakken L. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 2020; 52: 127-149 DOI: 10.1055/a-1075-4080. (PMID: 31863440)
• 4 Higa JT, Ross AS. Duodenoscope as a vector for transmission. Gastrointest Endosc Clin N Am 2020; 30: 653-663 DOI: 10.1016/j.giec.2020.05.002. (PMID: 32891223)
• 5 Humphries RM, Yang S, Kim S. et al. Duodenoscope-related outbreak of a carbapenem-resistant Klebsiella pneumoniae identified using advanced molecular diagnostics. Clin Infect Dis 2017; 65: 1159-1166 DOI: 10.1093/cid/cix527. (PMID: 29579235)
• 6 Rauwers AW, Voor In't Holt AF, Buijs JG. et al. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study. Gut 2018; 67: 1637-1645
• 7 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
• 8 Holzwanger EA, Bilal M, Saperia J. et al. Duodenoscope-related infections and potential role of single-use duodenoscopes. VideoGIE 2020; 5: 628-629 DOI: 10.1016/j.vgie.2020.08.011. (PMID: 33024906)
• 9 Beilenhoff U, Biering H, Blum R. et al. ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883–5. Endoscopy 2017; 49: 1262-1275 DOI: 10.1055/s-0043-122073. (PMID: 29145674)
• 10 Muthusamy VR, Bruno MJ, Kozarek RA. et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2020; 18: 2108-2117 DOI: 10.1016/j.cgh.2019.10.052. (PMID: 31706060)
• 11 Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut 2021; 70: 838-844 DOI: 10.1136/gutjnl-2020-321836. (PMID: 32895332)
• 12 Napoléon B, Gonzalez JM, Grandval P. et al. Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study. Dig Endosc 2022; 34: 215-221 DOI: 10.1111/den.13965. (PMID: 33666280)
• 13 Slivka A, Ross AS, Sejpal DV. et al. EXALT Single-use Duodenoscope Study Group. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc 2021; 94: 1046-1055
• 14 Rivallin P, Lorenzo D, Hedjoudje A. et al. Single-use duodenoscopes are an efficient tool for emergency ERCP in real life. Endosc Int Open 2022; 10: E1497-E1500 DOI: 10.1055/a-1921-2109. (PMID: 36397861)
• 15 Shahid HM, Bareket R, Tyberg A. et al. Comparing the safety and efficacy of two commercially available single-use duodenoscopes: a multicenter study. J Clin Gastroenterol 2023; 57: 798-803 DOI: 10.1097/MCG.0000000000001752. (PMID: 35997700)
• 16 Fugazza A, Colombo M, Kahaleh M. et al. 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. Hepatobiliary Pancreat Dis Int 2023; DOI: 10.1016/j.hbpd.2023.04.002.
• 17 Lagström R, Knuhtsen S, Stigaard T. et al. ERCP with single-use disposable duodenoscopes in four different set-ups. BMJ Case Rep 2023; 16: e251514
• 18 Persyn D, Malenstein HV, Vanderschueren E. et al. Performance and applicability of a first generation single-use duodenoscope: a single-center cohort study. Ann Gastroenterol 2022; 35: 368-375 DOI: 10.20524/aog.2022.0723. (PMID: 35784631)
• 19 Lisotti A, Zagari RM, Fusaroli P. et al. Optimal safety and pooled technical success rate for ERCP performed with single-use duodenoscopes. Dig Liver Dis 2022; 54: 291-292
• 20 Ramai D, Smit E, Kani HT. et al. Cannulation rates and technical performance evaluation of commercially available single-use duodenoscopes for endoscopic retrograde cholangiopancreatography: A systematic review and meta-analysis. Dig Liver Dis 2023; DOI: 10.1016/j.dld.2023.02.022.
• 21 Cennamo V, Landi S, Aragona G. et al. The management of endoscopic retrograde cholangiopancreatography-related infections risk: results of an Italian survey at regional level. Ann Ig 2023; 35: 84-91
• 22 Kiriyama S, Kozaka K, Takada T. et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci 2018; 25: 17-30
• 23 Miura F, Okamoto K, Takada T. et al. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci 2018; 25: 31-40 DOI: 10.1002/jhbp.509. (PMID: 28941329)
• 24 Veitch AM, Radaelli F, Alikhan R. et al. Endoscopy in patients on antiplatelet or anticoagulant therapy: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guideline update. Endoscopy 2021; 53: 947-969 DOI: 10.1136/gutjnl-2021-325184. (PMID: 34362780)
• 25 Trindade AJ, Copland A, Bhatt A. et al. Single-use duodenoscopes and duodenoscopes with disposable end caps. Gastrointest Endosc 2021; 93: 997-1005
• 26 Nass KJ, Zwager LW, van der Vlugt M. et al. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc 2022; 95: 1078-1085 DOI: 10.1016/j.gie.2021.11.038. (PMID: 34890695)
• 27 Rodríguez-Villodres Á, Martín-Gandul C, Peñalva G. et al. Prevalence and risk factors for multidrug-resistant organisms colonization in long-term care facilities around the world: a review. Antibiotics (Basel) 2021; 10: 680 DOI: 10.3390/antibiotics10060680. (PMID: 34200238)
• 28 Kwakman JA, Poley MJ, Vos MC. et al. Single-use duodenoscopes compared with reusable duodenoscopes in patients carrying multidrug-resistant microorganisms: a break-even cost analysis. Endosc Int Open 2023; 11: E571-E580
• 29 Lisotti A, Linguerri R, Bacchilega I. et al. EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-procedure outcomes and evaluation of mortality predictors. Surg Endosc 2022; 36: 569-578