A Prospective Multicenter Study of a Fully Covered Metal Stent in Patients with Distal Malignant Biliary Obstruction: WATCH-2 Study View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-12-07

AUTHORS

Hirofumi Kogure, Shomei Ryozawa, Iruru Maetani, Yousuke Nakai, Hiroshi Kawakami, Ichiro Yasuda, Hitoshi Mochizuki, Hirotoshi Iwano, Hiroyuki Maguchi, Mitsuhiro Kida, Kensuke Kubota, Tsuyoshi Mukai, Osamu Hasebe, Yoshinori Igarashi, Keiji Hanada, Atsushi Irisawa, Kei Ito, Takao Itoi, Hiroyuki Isayama

ABSTRACT

BackgroundBoth fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported.AimsThe aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS.MethodsThis was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival.ResultsA total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%).ConclusionsFCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO.Clinical Trial Registration NumberUMIN000007131. More... »

PAGES

2466-2473

Journal

TITLE

Digestive Diseases and Sciences

ISSUE

9

VOLUME

63

Author Affiliations

  • Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
  • Department of Gastroenterology, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka-shi, Saitama, Japan
  • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro, Tokyo, Japan
  • Department of Gastroenterology, Graduate School of Medicine, Hokkaido University, Kita 15 Nishi 7 Kita-ku, Sapporo, Japan
  • First Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, Japan
  • Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, Japan
  • Center for Gastroenterology, Teine-Keijinkai Hospital, 1-12-1-40, Maeda, Teine-ku, Sapporo, Japan
  • Department of Gastroenterology, Kitasato University East Hospital, 2-1-1, Asamizodai Minami-ku, Sagamihara, Japan
  • Division of Gastroenterology, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura Kanazawa-ku, Yokohama, Japan
  • Department of Gastroenterology, Gifu Municipal Hospital, 7-1 Kashima-shi, Gifu, Japan
  • Department of Gastroenterology, Nagano Municipal Hospital, 1333-1 Oaza Tomitake, Nagano, Japan
  • Division of Internal Medicine, Department of Gastroenterology and Hepatology, Omori Medical Center, Toho University, 6-11-1 Omori-Nishi Ota-ku, Tokyo, Japan
  • Department of Gastroenterology, Onomichi General Hospital, 1-10-23 Hirahara, Onomichi-shi, Hiroshima, Japan
  • Department of Gastroenterology, Aizu Medical Center, Fukushima Medical University, 21-2 Tanisawa Kawahigashi-machi, Aizuwakamatsu-shi, Fukushima, Japan
  • Department of Gastroenterology, Sendai City Medical Center, 5-2-1, Tsurugaya Miyagino-ku, Sendai-shi, Miyagi, Japan
  • Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan
  • Department of Gastroenterology, Graduate School of Medicine, Juntendo University, 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10620-017-4875-5

    DOI

    http://dx.doi.org/10.1007/s10620-017-4875-5

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1099698991

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29218484


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