PILOT STUDY OF A NOVEL, LARGE-BORE, FULLY COVERED SELF-EXPANDABLE METALLIC STENT FOR UNRESECTABLE DISTAL BILIARY MALIGNANCIES

DOI
  • MUKAI Tsuyoshi
    Department of Gastroenterology, Gifu Municipal Hospital.
  • YASUDA Ichiro
    Department of Gastroenterology, Teikyo University Mizonokuchi Hospital.
  • ISAYAMA Hiroyuki
    Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.
  • IWASHITA Takuji
    Department of Gastroenterology, Graduate School of Medicine, Gifu University.
  • ITOI Takao
    Department of Gastroenterology and Hepatology, Tokyo Medical University.
  • KAWAKAMI Hiroshi
    Department of Gastroenterology, Hokkaido University Graduate School of Medicine. Department of Gastroenterology and Hepatology, Center for Digestive Disease, The University of Miyazaki.
  • KOGURE Hirofumi
    Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.
  • NAKAI Yousuke
    Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.

Bibliographic Information

Other Title
  • 非切除悪性遠位胆管閉塞に対する大口径fully‒covered self‒expandable metallic stentの多施設共同観察研究

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Description

<p>Background and Aim : In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events.</p><p>Methods : This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement.</p><p>Results : Technical and functional success rates of the procedures were 100％. Six-month non-RBO rate was 50％, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26％), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at ＜30 days) developed in six patients (16％ ; cholecystitis, one ; pancreatitis, one ; hyperamylasemia, one ; pancreatic ductitis, one ; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients.</p><p>Conclusion : Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.</p>

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Details 詳細情報について

  • CRID
    1390282679197473024
  • NII Article ID
    130006176541
  • DOI
    10.11280/gee.59.2546
  • ISSN
    18845738
    03871207
  • Text Lang
    ja
  • Data Source
    • JaLC
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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