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Background <p>Although various self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction (MHBO) have been introduced, the optimal SEMS for MHBO has not yet been established.</p> Purpose <p>This study aimed to evaluate outcomes of the transpapillary placement of an uncovered laser-cut SEMS with an ultra-thin delivery sheath (YABUSAME) for MHBO.</p> Methods <p>This multicenter, prospective study was conducted in 11 hospitals for 10&#xa0;months (from March 2022 to December 2022). The primary outcome was the stent patency rate at 6&#xa0;months. Key secondary outcomes were the technical success rate, clinical success rate, time to recurrent biliary obstruction (RBO), overall survival (OS), and adverse events.</p> Results <p>Of 45 enrolled patients, 43 patients underwent biliary drainage, including 42 patients who underwent YABUSAME placement; 66.7% of patients received chemotherapy, and 60% had previously undergone biliary drainage. Drainage methods were partial stent-in-stent, side-by-side, and unilateral in 65.1%, 7.0%, and 27.9% of patients, respectively. Technical and clinical success rates were 93.2% (41/45) and 79.1% (34/45), respectively. The incidence rate of early postprocedural adverse events was 2.2%. The stent patency rate at 6&#xa0;months was 55.3%. The median time to RBO was 231&#xa0;days. The median OS was 125&#xa0;days.</p> Conclusion <p>This study showed that the primary outcome, the 6-month stent patency rate, exceeded the expected rate of 55%, which indicates the efficacy of YABUSAME placement for MHBO.</p>

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Uncovered Self-Expandable Metallic Stent with an Ultra-Thin Delivery Sheath in Unresectable Malignant Hilar Biliary Obstruction: A Multicenter Prospective Observational Study

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  • 发表日期：

    2025年2月19日

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  • Kotaro Takeshita,
  • Susumu Hijioka,
  • Kenji Ikezawa,
  • Takeshi Ogura,
  • Masaki Kuwatani,
  • Nao Fujimori,
  • Shinpei Doi,
  • Masato Endo,
  • Saburo Matsubara,
  • Reiko Yamada,
  • Hirosato Mashima,
  • Mikinori Kataoka,
  • Ryoji Takada,
  • Atsushi Okuda,
  • Akihisa Ohno,
  • Nobuhiro Katsukura,
  • Hirosumi Suzuki,
  • Takamitsu Tanaka,
  • Masanari Sekine,
  • Hidetoshi Kitamura,
  • Takuji Okusaka

摘要

Background

Although various self-expandable metallic stents (SEMSs) for malignant hilar biliary obstruction (MHBO) have been introduced, the optimal SEMS for MHBO has not yet been established.

Purpose

This study aimed to evaluate outcomes of the transpapillary placement of an uncovered laser-cut SEMS with an ultra-thin delivery sheath (YABUSAME) for MHBO.

Methods

This multicenter, prospective study was conducted in 11 hospitals for 10 months (from March 2022 to December 2022). The primary outcome was the stent patency rate at 6 months. Key secondary outcomes were the technical success rate, clinical success rate, time to recurrent biliary obstruction (RBO), overall survival (OS), and adverse events.

Results

Of 45 enrolled patients, 43 patients underwent biliary drainage, including 42 patients who underwent YABUSAME placement; 66.7% of patients received chemotherapy, and 60% had previously undergone biliary drainage. Drainage methods were partial stent-in-stent, side-by-side, and unilateral in 65.1%, 7.0%, and 27.9% of patients, respectively. Technical and clinical success rates were 93.2% (41/45) and 79.1% (34/45), respectively. The incidence rate of early postprocedural adverse events was 2.2%. The stent patency rate at 6 months was 55.3%. The median time to RBO was 231 days. The median OS was 125 days.

Conclusion

This study showed that the primary outcome, the 6-month stent patency rate, exceeded the expected rate of 55%, which indicates the efficacy of YABUSAME placement for MHBO.