Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction

Kazunori Nakaoka; Senju Hashimoto; Naoto Kawabe; Takuji Nakano; Toshiki Kan; Masashi Ohki; Yuka Ochi; Tomoki Takamura; Takamitsu Kurashita; Sayuri Nomura; Keishi Koyama; Aiko Fukui; Kentaro Yoshioka

doi:10.1055/a-0627-7078

Endoscopy International Open, Table of Contents

CC BY-NC-ND 4.0 · Endosc Int Open 2018; 06(10): E1164-E1170
DOI: 10.1055/a-0627-7078

Original article

Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction

Kazunori Nakaoka

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Senju Hashimoto

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Naoto Kawabe

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Takuji Nakano

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Toshiki Kan

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Masashi Ohki

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Yuka Ochi

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Tomoki Takamura

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Takamitsu Kurashita

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Sayuri Nomura

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Keishi Koyama

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Aiko Fukui

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

,

Kentaro Yoshioka

Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan

› Author Affiliations

Abstract

Background and study aims Biliary metallic stents are used to drain unresectable malignant distal biliary obstructions. This study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm CSEEMS).

Patients and methods We evaluated 99 patients with unresectable malignant distal biliary obstructions treated with covered biliary metallic stents. Of the 99 patients, 33 underwent 12-mm CSEEMS placement between June 2015 and April 2017 (12-mm-CSEEMS group) and 66 underwent 10-mm fully-covered self-expandable metal stent (FCSEMS) placement between January 2010 and July 2015 (10-mm-FCSEMS group). The overall survival (OS), the recurrent biliary obstruction (RBO), cause of RBO, time to RBO (TRBO) and adverse events in 12-mm-CSEEMS group and 10-mm-FCSEMS group were evaluated retrospectively.

Results The OS tended to be longer in the 12-mm-CSEEMS group (log rank, P = 0.081) and TRBO was significantly longer in the 12-mm-CSEEMS group (log rank, P = 0.001) than in the 10-mm-FCSEMS group. Both univariate (HR, 0.449; 95 % CI, 0.27967 – 0.72215; P = 0.001) and multivariate (HR, 0.458; 95 % CI, 0.28395 – 0.73744; P = 0.001) Cox hazard analysis found that risk of RBO was significantly lower in 12-mm CSEEMS than in 10-mm FCSEMS. There were no significant differences between the 12-mm-CSEEMS group and 10-mm-FCSEMS group regarding the cause of RBO and adverse events.

Conclusions The 12-mm CSEEMS showed a low risk of RBO compared with 10-mm FCSEMS and was considered to be effective and safe for draining unresectable malignant distal biliary obstruction.

Full Text

References

References
1 Irving JD, Adam A, Dick R. et al. Gianturco expandable metallic biliary stents: results of a European clinical trial. Radiology 1989; 172: 321-326
2 Lammer J, Klein GE, Kleinert R. et al. Obstructive jaundice: use of expandable metal endoprosthesis for biliary drainage. Work in progress. Radiology 1990; 177: 789-792
3 Davids PH, Groen AK, Rauws EA. et al. Randomised trial of self-expanding metal stents versus polyethylene stents for distal malignant biliary obstruction. Lancet 1992; 340: 1488-1492
4 Hoepffner N, Foerster EC, Hogemann B. et al. Long-term experience in Wallstent therapy for malignant choledochal stenosis. Endoscopy 1994; 26: 597-602
5 Isayama H, Komatsu Y, Tsujino T. et al. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729-734
6 Saleem A, Leggett CL, Murad MH. et al. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 2011; 74: 321-327.e321-323
7 Kitano M, Yamashita Y, Tanaka K. et al. Covered self-expandable metal stents with an anti-migration system improve patency duration without increased complications compared with uncovered stents for distal biliary obstruction caused by pancreatic carcinoma: a randomized multicenter trial. Am J Gastroenterol 2013; 108: 1713-1722
8 Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol 2013; 11: 27-37.e21
9 Mukai T, Yasuda I, Isayama H. et al. Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies. Dig Endosc 2016; 28: 671-679
10 Isayama H, Nakai Y, Toyokawa Y. et al. Measurement of radial and axial forces of biliary self-expandable metallic stents. Gastrointest Endosc 2009; 70: 37-44
11 Isayama H, Hamada T, Yasuda I. et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
12 Ramanathan RK, Goldstein D, Korn RL. et al. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol 2016; 27: 648-653
13 Conroy T, Desseigne F, Ychou M. et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 2011; 364: 1817-1825
14 Chen MY, Lin JW, Zhu HP. et al. Covered Stents versus uncovered stents for unresectable malignant biliary strictures: a meta-analysis. BioMed Res Int 2016; 2016: 6408067
15 Yang Z, Wu Q, Wang F. et al. A systematic review and meta-analysis of randomized trials and prospective studies comparing covered and bare self-expandable metal stents for the treatment of malignant obstruction in the digestive tract. Int J Med Sci 2013; 10: 825-835
16 Li J, Li T, Sun P. et al. Covered versus uncovered self-expandable metal stents for managing malignant distal biliary obstruction: a meta-analysis. PloS One 2016; 11: e0149066
17 Isayama H, Mukai T, Itoi T. et al. Comparison of partially covered nitinol stents with partially covered stainless stents as a historical control in a multicenter study of distal malignant biliary obstruction: the WATCH study. Gastrointest Endosc 2012; 76: 84-92
18 Kawakubo K, Isayama H, Nakai Y. et al. Risk factors for pancreatitis following transpapillary self-expandable metal stent placement. Surg Endosc 2012; 26: 771-776
19 Isayama H, Kawabe T, Nakai Y. et al. Cholecystitis after metallic stent placement in patients with malignant distal biliary obstruction. Clin Gastroenterol Hepatol 2006; 4: 1148-1153
20 Suk KT, Kim HS, Kim JW. et al. Risk factors for cholecystitis after metal stent placement in malignant biliary obstruction. Gastrointest Endosc 2006; 64: 522-529