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World J Methodol. Sep 20, 2026; 16(3): 116174
Published online Sep 20, 2026. doi: 10.5662/wjm.116174
Efficacy of duodenoscope with disposable distal cap in reducing microbial contamination: A systematic review and meta-analysis
Beanie Conceição Medeiros Nunes, Stefano Baraldo, Joao Ricardo Duda, Luiza Fenelon, Matheus Cavalcante Franco, Murilo Cavalcante Netto do Carmo, Diogo Bergesch Diedrich, Marcelo Cristalli Pacheco da Costa, Angelo So Taa Kum
Beanie Conceição Medeiros Nunes, Angelo So Taa Kum, Department of Gastroenterology Endoscopy Unit, Hospital das Clínicas, Faculty of Medicine, University of Sao Paulo, Sao Paulo 05403-010, SP, Brazil
Stefano Baraldo, Department of Endoscopy, Barretos Cancer Hospital, Barretos 14784-400, Sao Paulo, Brazil
Joao Ricardo Duda, Endoscopy Unit, Endoskope Diagnósticos Endoscópicos, Curitiba 80060-272, Paraná, Brazil
Luiza Fenelon, Endoscopy Unit, University of Sao Paulo University Hospital of Sao Paulo, Sao Paulo 05508-000, SP, Brazil
Matheus Cavalcante Franco, Division of Gastroenterology, UT Health San Antonio, San Antonio, TX 78229, United States
Murilo Cavalcante Netto do Carmo, Diogo Bergesch Diedrich, Hospital, Federal University of Health Sciences of Porto Alegre, Porto Alegre 90050-170, Rio Grande do Sul, Brazil
Marcelo Cristalli Pacheco da Costa, Endoscopy Unit, Unimed Sorocaba, Sorocaba 18052-775, SP, Brazil
Author contributions: Nunes BCM, Baraldo S, and Kum AST designed the conceptualization; Nunes BCM and Duda JR performed the data search and extraction; Franco MC and Kum AST performed the statistical analysis; Nunes BCM and Kum AST performed the original draft; Nunes BCM, Baraldo S, Duda JR, Fenelon L, Franco MC, do Carmo MCN, Diedrich DB, da Costa MCP, Kum AST participated in the writing, editing, read and approved the final manuscript.
AI contribution statement: The ChatGPT was used in parts of the main text of the manuscript (Abstract, Introduction, Discussion, and Conclusion) for the sole purpose of translation and language polishing. No AI tool was used in the design of the study or interpretation of its results. No images in the manuscript were generated by AI.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Corresponding author: Angelo So Taa Kum, MSc, MD, Senior Researcher, Department of Gastroenterology Endoscopy Unit, Hospital das Clínicas, Faculty of Medicine, University of Sao Paulo, Av. Dr Enéas de Carvalho Aguiar, 225, 6o andar, bloco 3, Cerqueira Cesar, Sao Paulo 05403-010, SP, Brazil.
angelo.kum@alumni.usp.br
Received: November 4, 2025
Revised: December 8, 2025
Accepted: February 9, 2026
Published online: September 20, 2026
Processing time: 248 Days and 8.4 Hours
BACKGROUND
Persistent microbial contamination of duodenoscopes remains a critical vector for healthcare-associated infections involving multidrug-resistant organisms. Despite adherence to standard high-level disinfection (HLD) protocols, contamination rates remain alarming. To mitigate this risk, the United States Food and Drug Administration has recommended transitioning to duodenoscopes with disposable components.
AIM
To investigate the efficacy of disposable distal cap compared to standard duodenoscope reprocessing with HLD in reducing microbial contamination.
METHODS
Following Preferred Reporting Items for Systematic Reviews and Meta-analysis and Cochrane guidelines, we conducted a systematic search of MEDLINE, EMBASE, Google Scholar, and grey literature for randomized controlled trials comparing disposable distal cap vs standard duodenoscopes. The primary outcome was the rate of microbial contamination, defined as an adenosine triphosphate level > 40 relative light unit. Risk ratio was pooled using a random-effects model, and the quality of evidence was assessed using the Grading Recommendations Assessment, Development, and Evaluation methodology.
RESULTS
Four randomized controlled trials met the inclusion criteria, encompassing 1092 duodenoscopes (543 disposable distal cap, 549 standard). The use of disposable cap demonstrated a significant and substantial reduction in post-HLD contamination rates. The pooled analysis showed a risk ratio of 0.32 (95% confidence interval: 0.16-0.67; P = 0.003), representing a 68% reduction in contamination risk. No statistical heterogeneity was detected (I2 = 0%). The overall quality of evidence for this outcome was rated as high.
CONCLUSION
Disposable distal cap significantly decreases microbial contamination rates compared to standard duodenoscope reprocessing protocols. This technology represents a robust and effective strategy to enhance the safety of duodenoscope reprocessing.
Core Tip: This systematic review and meta-analysis synthesize data from four randomized controlled trials, providing high-quality evidence that disposable distal caps are a highly effective solution to duodenoscope contamination. The primary finding demonstrates a 68% relative risk reduction in microbial contamination, as measured by adenosine triphosphate levels, following high-level disinfection when compared to standard duodenoscopes. This study strongly supports the adoption of disposable distal caps technology as a critical engineering control to enhance reprocessing safety and mitigate the transmission of healthcare-associated infections.
