Hirofumi Kogure1, Shomei Ryozawa2, Iruru Maetani3, Yousuke Nakai1, Hiroshi Kawakami4, Ichiro Yasuda5, Hitoshi Mochizuki6, Hirotoshi Iwano2, Hiroyuki Maguchi7, Mitsuhiro Kida8, Kensuke Kubota9, Tsuyoshi Mukai10, Osamu Hasebe11, Yoshinori Igarashi12, Keiji Hanada13, Atsushi Irisawa14, Kei Ito15, Takao Itoi16, Hiroyuki Isayama17,18. 1. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. 2. Department of Gastroenterology, International Medical Center, Saitama Medical University, 1397-1, Yamane, Hidaka-shi, Saitama, Japan. 3. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6, Ohashi, Meguro, Tokyo, Japan. 4. Department of Gastroenterology, Graduate School of Medicine, Hokkaido University, Kita 15 Nishi 7 Kita-ku, Sapporo, Japan. 5. First Department of Internal Medicine, Gifu University Hospital, 1-1 Yanagido, Gifu, Japan. 6. Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 Fujimi, Kofu, Japan. 7. Center for Gastroenterology, Teine-Keijinkai Hospital, 1-12-1-40, Maeda, Teine-ku, Sapporo, Japan. 8. Department of Gastroenterology, Kitasato University East Hospital, 2-1-1, Asamizodai Minami-ku, Sagamihara, Japan. 9. Division of Gastroenterology, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura Kanazawa-ku, Yokohama, Japan. 10. Department of Gastroenterology, Gifu Municipal Hospital, 7-1 Kashima-shi, Gifu, Japan. 11. Department of Gastroenterology, Nagano Municipal Hospital, 1333-1 Oaza Tomitake, Nagano, Japan. 12. Division of Internal Medicine, Department of Gastroenterology and Hepatology, Omori Medical Center, Toho University, 6-11-1 Omori-Nishi Ota-ku, Tokyo, Japan. 13. Department of Gastroenterology, Onomichi General Hospital, 1-10-23 Hirahara, Onomichi-shi, Hiroshima, Japan. 14. Department of Gastroenterology, Aizu Medical Center, Fukushima Medical University, 21-2 Tanisawa Kawahigashi-machi, Aizuwakamatsu-shi, Fukushima, Japan. 15. Department of Gastroenterology, Sendai City Medical Center, 5-2-1, Tsurugaya Miyagino-ku, Sendai-shi, Miyagi, Japan. 16. Department of Gastroenterology and Hepatology, Tokyo Medical University, 6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, Japan. 17. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. isayama-tky@umin.ac.jp. 18. Department of Gastroenterology, Graduate School of Medicine, Juntendo University, 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan. isayama-tky@umin.ac.jp.
Abstract
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.
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.
Entities:
Keywords:
Endoscopic retrograde cholangiopancreatography; Malignant biliary obstruction; Self-expandable metal stent
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