Abstract
Background and aims
A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth.
Patients and methods
We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.).
Results
The mean age was 66.6 years (range, 35–83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration.
Conclusions
The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.
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Author contributions
MJC, CMN, SB, and SWP contributed to conception and design of the study. MJC and HJL helped with generation, collection, assembly, analysis, and/or interpretation of data. HJL, MJC, and SB helped in drafting and/or revision of the manuscript. JYP, SB, SWP, and SYS helped with critical revision of the article for important intellectual content. SB contributed to approval of the final version of the manuscript.
Disclosures
Drs. HJL, MJC, JYP, SWP, CMN, SYS, and SB have no conflicts of interest or financial ties to disclose.
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Hyun Jik Lee and Moon Jae Chung are contributed equally to this work.
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Lee, H.J., Chung, M.J., Park, J.Y. et al. A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction. Surg Endosc 31, 3159–3167 (2017). https://doi.org/10.1007/s00464-016-5341-8
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DOI: https://doi.org/10.1007/s00464-016-5341-8