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Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis

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Abstract

Background and aims

Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS.

Patients and methods

This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan–Meier analysis.

Results

Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005).

Conclusion

MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.

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Acknowledgements

All authors acknowledge Dr. Makoto Kobayashi, Division of Gastroenterology, Yokkaichi Municipal Hospital, Yokkaichi, Mie 5108657, Japan, for the conceptual design of this MHSEMS, and also Prof. Stephen J Kerr PhD, Biostatistics Excellence Center, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand, for the advice of statistical analysis. Part of the abstract in this study was presented at Digestive Disease Week (DDW) 2022, San Diego, USA.

Funding

This research received funding from Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund, Chulalongkorn University, and the Center of Excellence for Innovation and Endoscopy in Gastrointestinal Oncology. M.I. Tech Co. provided all MHSEMS used in this study and supported the study with an unrestricted grant without direct discretion to this manuscript.

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Authors and Affiliations

  1. Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand

    Santi Kulpatcharapong, Panida Piyachaturawat, Parit Mekaroonkamol, Wiriyaporn Ridtitid, Pradermchai Kongkam & Rungsun Rerknimitr

  2. Department of Anatomy, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand

    Phonthep Angsuwatcharakon

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  1. Santi Kulpatcharapong
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Contributions

Conceptualization and design (RR, SK), data collection (RR, SK, PP, PA, PK, WR, PM), data analysis and interpretation (SK, PP), manuscript drafting (SK), critical revision of the article for important intellectual content (RR, PA, PK, WR, PM), and final approval of the article (RR, SK, PP, PA, PK, WR, PM).

Corresponding author

Correspondence to Rungsun Rerknimitr.

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Santi Kulpatcharapong, Panida Piyachaturawat, Parit Mekaroonkamol, Phonthep Angsuwatcharakon, Wiriyaporn Ridtitid, Pradermchai Kongkam, and Rungsun Rerknimitr have no conflicts of interest or financial ties to disclose.

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Kulpatcharapong, S., Piyachaturawat, P., Mekaroonkamol, P. et al. Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis. Surg Endosc 38, 212–221 (2024). https://doi.org/10.1007/s00464-023-10541-9

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