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Letter to the Editor From dogma to individualized care: the potential of 6-mm fully covered self-expandable metal stent in unresectable malignant distal biliary obstruction
Hyung Ku Chonorcid

DOI: https://doi.org/10.5946/ce.2025.061
Published online: June 16, 2025

Division of Biliopancreas, Department of Internal Medicine, Institute of Wonkwang Medical Science, Wonkwang University College of Medicine, Iksan, Korea

Correspondence: Hyung Ku Chon Division of Biliopancreas, Department of Internal Medicine, Institute of Wonkwang Medical Science, Wonkwang University College of Medicine, 895 Muwang-ro, Iksan 54538, Korea E-mail: gipb2592@wku.ac.kr
• Received: February 24, 2025   • Revised: April 1, 2025   • Accepted: April 13, 2025

© 2025 Korean Society of Gastrointestinal Endoscopy

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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In the management of unresectable malignant distal biliary obstruction (UR-MDBO), optimal stent selection is a critical clinical challenge that must balance effective bile drainage with minimal stent-related complications.1,2 We read with great interest the recent study by Yamashige et al.3 investigating the potential use of 6-mm fully covered self-expandable metal stents (FCSEMSs) in managing UR-MDBO. A 6-mm FCSEMS has not been widely used in this setting due to concerns regarding insufficient drainage capacity, increased risk of stent migration, and inadequate radial force to counteract the compressive effects of malignant tumors. These limitations have favored the use of a larger diameter (typically 10 mm) FCSEMS to ensure optimal luminal patency and stability.4,5 However, Yamashige et al.3 provide compelling evidence that 6-mm FCSEMS can reduce stent‐related complications—particularly post-deployment cholecystitis—while maintaining stent patency comparable to that of the more traditionally used 10-mm FCSEMS in patients with UR-MDBO. This finding is particularly interesting given the conventional reluctance to use a 6-mm FCSEMS in this clinical context.
The lower complication rate observed with the 6-mm FCSEMS is clinically significant, especially in younger patients and those requiring palliative care, where minimizing procedure-related morbidity is paramount. However, the increased risk of stent migration associated with the 6-mm device remains a critical concern. This necessitates careful weighing of the benefits of reduced adverse events against the potential need for additional interventions owing to stent displacement.
Although the study employed propensity score matching to control for confounding factors, its retrospective design and relatively short follow-up period limited the assessment of long-term outcomes such as delayed stent occlusion, tumor ingrowth, or chronic migration-related complications. Additionally, a key methodological consideration was the use of different stent brands for each diameter group. The 10-mm FCSEMS used in the study was the BONASTENT (Standard Sci-Tech), while the 6-mm FCSEMSs included the HANAROSTENT (Boston Scientific) and EGIS biliary stents (Sumitomo Bakelite). Given that each stent has distinct covering materials, radial and axial forces, final expansion diameters, and degrees of compression on adjacent structures, such as the cystic and pancreatic ducts, these factors introduce additional confounders beyond the stent diameter alone. Differences in stent design characteristics may significantly influence the migration risk and stent-related complications, necessitating further investigation.
Future research should focus on prospective randomized controlled trials using the same stent model for both 6-mm and 10-mm FCSEMSs to determine whether stent diameter alone is the primary factor affecting clinical outcomes. Long-term outcome assessments are warranted to comprehensively assess delayed complications. Additionally, further investigations into patient-specific factors, such as biliary duct anatomy and tumor characteristics, and their influence on stent performance are essential to establish optimal stent selection criteria.
In conclusion, while conventional practice has been cautious about the use of 6-mm FCSEMS in UR-MDBO due to concerns over drainage efficiency and migration, the study by Yamashige et al.3 represents a significant contribution that challenges this paradigm. By demonstrating the potential benefits of a smaller-diameter stent despite its inherent risks, this research lays the foundation for more personalized and effective treatment strategies. Along with this shift in clinical practice, the impetus for developing innovative stent technologies is clearer than ever, offering the promise of improved outcomes through refined patient-specific device design.
  • 1. Sakai A, Masuda A, Eguchi T, et al. A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study. Clin Endosc 2024;57:375–383.ArticlePubMedPMCPDF
  • 2. Kitagawa K, Mitoro A, Ozutsumi T, et al. Laser-cut-type versus braided-type covered self-expandable metallic stents for distal biliary obstruction caused by pancreatic carcinoma: a retrospective comparative cohort study. Clin Endosc 2022;55:434–442.ArticlePubMedPMCPDF
  • 3. Yamashige D, Hijioka S, Nagashio Y, et al. Potential of 6-mm-diameter fully covered self-expandable metal stents for unresectable malignant distal biliary obstruction: a propensity score-matched study. Clin Endosc 2025;58:121–133.ArticlePubMedPMCPDF
  • 4. Kawashima H, Hashimoto S, Ohno E, et al. Comparison of 8- and 10-mm diameter fully covered self-expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction. Dig Endosc 2019;31:439–447.ArticlePubMedPDF
  • 5. Ghazi R, AbiMansour JP, Mahmoud T, et al. Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction. Gastrointest Endosc 2023;98:577–584.ArticlePubMed

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