TY - JOUR
T1 - Comparison of 8- and 10-mm diameter fully covered self-expandable metal stents
T2 - A multicenter prospective study in patients with distal malignant biliary obstruction
AU - The Nagoya Biliary Stent Study (NABIS)-01 Group
AU - Kawashima, Hiroki
AU - Hashimoto, Senju
AU - Ohno, Eizaburo
AU - Ishikawa, Takuya
AU - Morishima, Tomomasa
AU - Matsubara, Hiroshi
AU - Sugimoto, Hiroyuki
AU - Nonogaki, Koji
AU - Kanamori, Akira
AU - Hara, Kazuo
AU - Kuwahara, Takamichi
AU - Nakamura, Masanao
AU - Miyahara, Ryoji
AU - Ishigami, Masatoshi
AU - Ando, Masahiko
AU - Hirooka, Yoshiki
N1 - Publisher Copyright:
© 2019 Japan Gastroenterological Endoscopy Society
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/7
Y1 - 2019/7
N2 - Objectives: The time to recurrent biliary obstruction (TRBO) of unresectable distal malignant biliary obstruction is generally thought to be longer when a self-expandable metal stent (SEMS) with a thicker inner diameter is used for drainage, but the dependence on the inner diameter using a fully covered SEMS (FCSEMS) is uncertain. The objective of this multicenter prospective study was to compare TRBO and adverse events, such as cholecystitis and pancreatitis, in treatment of patients with unresectable malignant biliary obstruction using 8- and 10-mm diameter FCSEMS. Methods: Eighteen tertiary-care centers participated in the study. Patients were allocated to the 8- and 10-mm diameter groups. TRBO, non-inferiority of the 8-mm FCSEMS, overall survival time, frequency and type of adverse events, and non-recurrent biliary obstruction (RBO) rate at the time of death were compared between the two groups. Results: Median TRBO did not differ significantly between the 8-mm (n = 102) and 10-mm (n = 100) groups (275 vs 293 days, P = 0.971). The hazard ratio of the 8- to 10-mm groups was 0.90 (80% confidence interval, 0.77–1.04; upper limit lower than the acceptable hazard ratio [1.33] of the null hypothesis). Based on these findings, the 8-mm diameter stent was determined to be non-inferior to the 10-mm diameter stent. Survival time, incidence of adverse events and non-RBO rate at the time of death did not differ significantly between the two groups. Conclusions: Time to RBO with an 8-mm diameter FCSEMS was non-inferior to that with a 10-mm diameter FCSEMS. This finding is important for development of future SEMS.
AB - Objectives: The time to recurrent biliary obstruction (TRBO) of unresectable distal malignant biliary obstruction is generally thought to be longer when a self-expandable metal stent (SEMS) with a thicker inner diameter is used for drainage, but the dependence on the inner diameter using a fully covered SEMS (FCSEMS) is uncertain. The objective of this multicenter prospective study was to compare TRBO and adverse events, such as cholecystitis and pancreatitis, in treatment of patients with unresectable malignant biliary obstruction using 8- and 10-mm diameter FCSEMS. Methods: Eighteen tertiary-care centers participated in the study. Patients were allocated to the 8- and 10-mm diameter groups. TRBO, non-inferiority of the 8-mm FCSEMS, overall survival time, frequency and type of adverse events, and non-recurrent biliary obstruction (RBO) rate at the time of death were compared between the two groups. Results: Median TRBO did not differ significantly between the 8-mm (n = 102) and 10-mm (n = 100) groups (275 vs 293 days, P = 0.971). The hazard ratio of the 8- to 10-mm groups was 0.90 (80% confidence interval, 0.77–1.04; upper limit lower than the acceptable hazard ratio [1.33] of the null hypothesis). Based on these findings, the 8-mm diameter stent was determined to be non-inferior to the 10-mm diameter stent. Survival time, incidence of adverse events and non-RBO rate at the time of death did not differ significantly between the two groups. Conclusions: Time to RBO with an 8-mm diameter FCSEMS was non-inferior to that with a 10-mm diameter FCSEMS. This finding is important for development of future SEMS.
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U2 - 10.1111/den.13366
DO - 10.1111/den.13366
M3 - Article
C2 - 30714216
AN - SCOPUS:85063649989
VL - 31
SP - 439
EP - 447
JO - Digestive Endoscopy
JF - Digestive Endoscopy
SN - 0915-5635
IS - 4
ER -