TY - JOUR
T1 - Impact of anticancer treatment on recurrent obstruction in covered metallic stents for malignant biliary obstruction
AU - Nakai, Yousuke
AU - Isayama, Hiroyuki
AU - Mukai, Tsuyoshi
AU - Itoi, Takao
AU - Maetani, Iruru
AU - Kawakami, Hiroshi
AU - Yasuda, Ichiro
AU - Maguchi, Hiroyuki
AU - Ryozawa, Shomei
AU - Hanada, Keiji
AU - Hasebe, Osamu
AU - Ito, Kei
AU - Kawamoto, Hiorofumi
AU - Mochizuki, Hitoshi
AU - Igarashi, Yoshinori
AU - Irisawa, Atsushi
AU - Sasaki, Tamito
AU - Togawa, Osamu
AU - Hara, Taro
AU - Kamada, Hideki
AU - Toda, Nobuo
AU - Hamada, Tsuyoshi
AU - Kogure, Hirofumi
N1 - Funding Information:
This study was supported by a grant of the Japanese Foundation for Research and Promotion of Endoscopy. We thank the following investigators and clinical research coordinators. Investigators of the study: Naoki Sasahira, MD, Kenji Hirano, MD, Natsuyo Yamamoto, MD, Yukiko Ito, MD, Yoko Yashima, MD, Suguru Mizuno, MD—Department of Gastroenterology, Graduate School of Medicine, Tokyo, Japan; Masaki Kuwatani, MD, Manabu Onodera, MD, Shin Haba, MD—Department of Gastroenterology, Hokkaido University Graduate School of Medicine; Shinpei Doi, MD—First Department of Internal medicine, Gifu University Hospital, Gifu, Japan; Manabu Osanai, MD—Center for Gastroenterology, Teine-Keijinkai Hospital, Hokkaido, Japan; Hirotoshi Iwano, MD—Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan; Yasuhide Ochi, MD—Department of Gastroenterology, Nagano Municipal Hospital, Nagano, Japan; Naotaka Fujita, MD—Department of Gastroenterology, Sendai City Medical Center, Sendai, Japan; Hironari Kato, MD—Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science, Okayama, Japan; Masao Omata, MD—Yamanashi Prefectural Hospital Organization, Yamanashi, Japan; Tadayuki Takagi, MD, Tsunehiko Ikeda, MD, Rei Suzuki, MD, Hiromasa Ohira—Department of Gastroenterology and Rheumatology, Division of Medicine, Fukushima Medical University School of Medicine, Fukushima, Japan; Hiroto Kita, MD—Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama, Japan; Taketo Yamaguchi, MD—Department of Gastroenterology, Chiba Cancer Center, Chiba, Japan; Tsutomu Masaki, MD—Department of Gastroenterology and Neurology Faculty of Medicine, Kagawa University, Kagawa, Japan. Clinical study coordinators: Miyuki Tsuchida, Makiko Otake—Clinical Research Support Center, Tokyo University Hospital, Tokyo, Japan.
PY - 2013/11
Y1 - 2013/11
N2 - Background: In patients with unresectable malignant biliary obstruction (MBO), anticancer treatment is often administered. The impact of anticancer treatment on recurrent biliary obstruction in covered self-expandable metallic stents (SEMS) has not been fully elucidated. Methods: Data on 279 patients enrolled in a multicenter prospective cohort study of two different covered SEMS for distal MBO, WATCH study (141 partially covered WallFlex stents and 138 partially covered Wallstents) were retrospectively analyzed. The rates and causes of recurrent biliary obstruction (stent occlusion or migration) were compared between anticancer treatment group (n = 173) and best supportive care alone (BSC) group (n = 106). Cumulative time and prognostic factors for recurrent biliary obstruction were analyzed, using a proportional hazards model with death without recurrent biliary obstruction as a competing risk. Results: The overall rate (43 vs. 25 %, P = 0.002) and the cumulative incidence (16.1 vs. 8.2, 27.9 vs. 18.9 and 44.1 vs. 26.6 % at 3, 6 and 12 months, P = 0.030 by Gray's test) of recurrent biliary obstruction were significantly higher in anticancer treatment group compared with BSC group. The multivariate analysis revealed anticancer treatment [subdistribution hazard ratio (SHR) 1.93, P = 0.007) as well as the use of a partially covered WallFlex stent (SHR 0.65, P = 0.049) as prognostic factors. Conclusions: Anticancer treatment was a risk factor for recurrent biliary obstruction in covered SEMS for distal MBO. The superiority of a partially covered WallFlex stent was again confirmed in this competing risk analysis; UMIN-CTR: UMIN000002293.
AB - Background: In patients with unresectable malignant biliary obstruction (MBO), anticancer treatment is often administered. The impact of anticancer treatment on recurrent biliary obstruction in covered self-expandable metallic stents (SEMS) has not been fully elucidated. Methods: Data on 279 patients enrolled in a multicenter prospective cohort study of two different covered SEMS for distal MBO, WATCH study (141 partially covered WallFlex stents and 138 partially covered Wallstents) were retrospectively analyzed. The rates and causes of recurrent biliary obstruction (stent occlusion or migration) were compared between anticancer treatment group (n = 173) and best supportive care alone (BSC) group (n = 106). Cumulative time and prognostic factors for recurrent biliary obstruction were analyzed, using a proportional hazards model with death without recurrent biliary obstruction as a competing risk. Results: The overall rate (43 vs. 25 %, P = 0.002) and the cumulative incidence (16.1 vs. 8.2, 27.9 vs. 18.9 and 44.1 vs. 26.6 % at 3, 6 and 12 months, P = 0.030 by Gray's test) of recurrent biliary obstruction were significantly higher in anticancer treatment group compared with BSC group. The multivariate analysis revealed anticancer treatment [subdistribution hazard ratio (SHR) 1.93, P = 0.007) as well as the use of a partially covered WallFlex stent (SHR 0.65, P = 0.049) as prognostic factors. Conclusions: Anticancer treatment was a risk factor for recurrent biliary obstruction in covered SEMS for distal MBO. The superiority of a partially covered WallFlex stent was again confirmed in this competing risk analysis; UMIN-CTR: UMIN000002293.
KW - Chemotherapy
KW - Competing risk analysis
KW - Covered metallic stents
KW - Obstructive jaundice
UR - http://www.scopus.com/inward/record.url?scp=84889883604&partnerID=8YFLogxK
U2 - 10.1007/s00535-013-0749-6
DO - 10.1007/s00535-013-0749-6
M3 - 学術論文
C2 - 23354624
AN - SCOPUS:84889883604
SN - 0944-1174
VL - 48
SP - 1293
EP - 1299
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
IS - 11
ER -