TY - JOUR
T1 - A Prospective Multicenter Study of a Fully Covered Metal Stent in Patients with Distal Malignant Biliary Obstruction
T2 - WATCH-2 Study
AU - Kogure, Hirofumi
AU - Ryozawa, Shomei
AU - Maetani, Iruru
AU - Nakai, Yousuke
AU - Kawakami, Hiroshi
AU - Yasuda, Ichiro
AU - Mochizuki, Hitoshi
AU - Iwano, Hirotoshi
AU - Maguchi, Hiroyuki
AU - Kida, Mitsuhiro
AU - Kubota, Kensuke
AU - Mukai, Tsuyoshi
AU - Hasebe, Osamu
AU - Igarashi, Yoshinori
AU - Hanada, Keiji
AU - Irisawa, Atsushi
AU - Ito, Kei
AU - Itoi, Takao
AU - Isayama, Hiroyuki
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Background: Both 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. Aims: The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS. Methods: This 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. Results: A 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%). Conclusions: FCSEMSs 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 Number: UMIN000007131.
AB - Background: Both 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. Aims: The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS. Methods: This 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. Results: A 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%). Conclusions: FCSEMSs 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 Number: UMIN000007131.
KW - Endoscopic retrograde cholangiopancreatography
KW - Malignant biliary obstruction
KW - Self-expandable metal stent
UR - http://www.scopus.com/inward/record.url?scp=85037360225&partnerID=8YFLogxK
U2 - 10.1007/s10620-017-4875-5
DO - 10.1007/s10620-017-4875-5
M3 - 学術論文
C2 - 29218484
AN - SCOPUS:85037360225
SN - 0163-2116
VL - 63
SP - 2466
EP - 2473
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 9
ER -