Prospective comparison of endoscopic bilateral stent-in-stent versus stent-by-stent deployment for inoperable advanced malignant hilar biliary stricture

Published:March 21, 2019DOI:

      Background and Aims

      Although the efficacy of palliative bilateral biliary drainage using self-expandable metal stents has been demonstrated, it is unclear which bilateral method is optimal for advanced malignant hilar biliary strictures (MHSs). This pilot study compared bilateral stent-in-stent (SIS) with stent-by-stent (SBS) deployment for advanced MHSs.


      Patients with inoperable high-grade MHSs were enrolled in this prospective randomized multicenter study. The primary outcome was the rate of adverse events, whereas secondary outcomes were technical and clinical success, reintervention, therapeutic outcomes, stent patency, and survival duration.


      This study randomized 69 of 74 pathologically diagnosed patients to the SIS (n = 34) or SBS (n = 35) groups. The total adverse event rate after stent deployment did not differ between the 2 groups (23.5% in the SIS group vs 28.6% in the SBS group, P = .633). The primary technical success rate was 100% (34/34) and 91.4% (32/35) in the SIS and SBS groups, respectively (P = .081). The clinical success rate was 94.1% (32/34) and 90.6% (29/32), respectively (P = .668). The stent patency rate at 3 months was 85.3% in the SIS group and 65.7% in the SBS group (P = .059). At 6 months, the stent patency rate was 47.1% and 31.4%, respectively (P = .184). The median cumulative stent patency and survival probability did not differ between the 2 groups.


      Efficacy of bilateral SIS and SBS deployment may be similar in terms of total adverse events, technical and clinical success, stent patency, and survival. The stent patency rates at 3 and 6 months was higher in the SIS group without statistical difference. (Clinical trial registration number: NCT01141088.)


      IHD (intrahepatic duct), MHS (malignant hilar biliary stricture), SBS (stent-by-stent), SEMS (self-expandable metal stent), SIS (stent-in-stent)
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        • Cheng J.L.
        • Bruno M.J.
        • Bergman J.J.
        • et al.
        Endoscopic palliation of patients with biliary obstruction caused by nonresectable hilar cholangiocarcinoma: efficacy of self-expandable metallic Wallstents.
        Gastrointest Endosc. 2002; 56: 33-39
        • Hwang J.C.
        • Kim J.H.
        • Lim S.G.
        • et al.
        Y-shaped endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: prospective long-term study.
        Scand J Gastroenterol. 2011; 46: 326-332
        • Kato H.
        • Tsutsumi K.
        • Harada R.
        • et al.
        Endoscopic bilateral deployment of multiple metallic stents for malignant hilar biliary strictures.
        Dig Endosc. 2013; 25: 75-80
        • Kawamoto H.
        • Tsutsumi K.
        • Fujii M.
        • et al.
        Endoscopic 3-branched partial stent-in-stent deployment of metallic stents in high-grade malignant hilar biliary stricture (with videos).
        Gastrointest Endosc. 2007; 66: 1030-1037
        • Kogure H.
        • Isayama H.
        • Nakai Y.
        • et al.
        Newly designed large cell Niti-S stent for malignant hilar biliary obstruction: a pilot study.
        Surg Endosc. 2011; 25: 463-467
        • Lee T.H.
        Technical tips and issues of biliary stenting, focusing on malignant hilar obstruction.
        Clin Endosc. 2013; 46: 260-266
        • Lee T.H.
        • Moon J.H.
        • Kim J.H.
        • et al.
        Primary and revision efficacy of cross-wired metallic stents for endoscopic bilateral stent-in-stent placement in malignant hilar biliary strictures.
        Endoscopy. 2013; 45: 106-113
        • Lee T.H.
        • Park do H.
        • Lee S.S.
        • et al.
        Technical feasibility and revision efficacy of the sequential deployment of endoscopic bilateral side-by-side metal stents for malignant hilar biliary strictures: a multicenter prospective study.
        Dig Dis Sci. 2013; 58: 547-555
        • Liberato M.J.
        • Canena J.M.
        Endoscopic stenting for hilar cholangiocarcinoma: efficacy of unilateral and bilateral placement of plastic and metal stents in a retrospective review of 480 patients.
        BMC Gastroenterol. 2012; 12: 103
        • Mukai T.
        • Yasuda I.
        • Nakashima M.
        • et al.
        Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial.
        J Hepatobil Pancreat Sci. 2013; 20: 214-222
        • Naitoh I.
        • Hayashi K.
        • Nakazawa T.
        • et al.
        Side-by-side versus stent-in-stent deployment in bilateral endoscopic metal stenting for malignant hilar biliary obstruction.
        Dig Dis Sci. 2012; 57: 3279-3285
        • Park do H.
        • Lee S.S.
        • Moon J.H.
        • et al.
        Newly designed stent for endoscopic bilateral stent-in-stent placement of metallic stents in patients with malignant hilar biliary strictures: multicenter prospective feasibility study (with videos).
        Gastrointest Endosc. 2009; 69: 1357-1360
        • Lee T.H.
        • Moon J.H.
        • Choi H.J.
        • et al.
        Third metal stent for revision of malignant hilar biliary strictures.
        Endoscopy. 2016; 48: 1129-1133
        • Kim J.Y.
        • Kang D.H.
        • Kim H.W.
        • et al.
        Usefulness of slimmer and open-cell-design stents for endoscopic bilateral stenting and endoscopic revision in patients with hilar cholangiocarcinoma (with video).
        Gastrointest Endosc. 2009; 70: 1109-1115
        • Rerknimitr R.
        • Angsuwatcharakon P.
        • Ratanachu-ek T.
        • et al.
        Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma.
        J Gastroenterol Hepatol. 2013; 28: 593-607
        • Kogure H.
        • Isayama H.
        • Nakai Y.
        • et al.
        High single-session success rate of endoscopic bilateral stent-in-stent placement with modified large cell Niti-S stents for malignant hilar biliary obstruction.
        Dig Endosc. 2014; 26: 93-99
        • Naitoh I.
        • Ohara H.
        • Nakazawa T.
        • et al.
        Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction.
        J Gastroenterol Hepatol. 2009; 24: 552-557
        • Chennat J.
        • Waxman I.
        Initial performance profile of a new 6F self-expanding metal stent for palliation of malignant hilar biliary obstruction.
        Gastrointest Endosc. 2010; 72: 632-636
        • Moon J.H.
        • Rerknimitr R.
        • Kogure H.
        • et al.
        Topic controversies in the endoscopic management of malignant hilar strictures using metal stent: side-by-side versus stent-in-stent techniques.
        J Hepatobil Pancreat Sci. 2015; 22: 650-656
        • Kim K.M.
        • Lee K.H.
        • Chung Y.H.
        • et al.
        A comparison of bilateral stenting methods for malignant hilar biliary obstruction.
        Hepatogastroenterology. 2012; 59: 341-346
        • Jang R.W.
        • Caraiscos V.B.
        • Swami N.
        • et al.
        Simple prognostic model for patients with advanced cancer based on performance status.
        J Oncol Pract. 2014; 10: e335-e341
        • Hemming A.W.
        • Reed A.I.
        • Fujita S.
        • et al.
        Surgical management of hilar cholangiocarcinoma.
        Ann Surg. 2005; 241 (discussion 699-702): 693-699
        • Jarnagin W.R.
        • Fong Y.
        • DeMatteo R.P.
        • et al.
        Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma.
        Ann Surg. 2001; 234 (discussion 517-9): 507-517
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Cosgrove N.
        • Siddiqui A.A.
        • Adler D.G.
        • et al.
        A comparison of bilateral side-by-side metal stents deployed above and across the sphincter of Oddi in the management of malignant hilar biliary obstruction.
        J Clin Gastroenterol. 2017; 51: 528-533

      Linked Article

      • Side by side or stent within stent: the beauty is in the eye of the beholder
        Gastrointestinal EndoscopyVol. 90Issue 2
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          We read with much interest the article by Lee et al1 entitled “Prospective comparison of endoscopic bilateral stent-in-stent (SIS) versus stent-by-side (SBS) deployment for inoperable advanced malignant biliary stricture.” The intervention in question is the choice between an SBS deployment of uncovered stents versus an SIS deployment of self-expanding metallic stents in bilateral hepatic ducts for inoperable malignant biliary obstruction.
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