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A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction

Authors
 Hyun Jik Lee  ;  Moon Jae Chung  ;  Jeong Yup Park  ;  Seung Woo Park  ;  Chung Mo Nam  ;  Si Young Song  ;  Seungmin Bang 
Citation
 SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, Vol.31(8) : 3159-3167, 2017 
Journal Title
 SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES 
ISSN
 0930-2794 
Issue Date
2017
MeSH
Adult ; Aged ; Aged, 80 and over ; Cholestasis/surgery* ; Equipment Design ; Female ; Humans ; Male ; Middle Aged ; Pancreatic Neoplasms/surgery* ; Postoperative Complications ; Prospective Studies ; Stents* ; Treatment Outcome
Keywords
ERCP ; Extrahepatic biliary obstruction ; Malignant bile duct obstruction ; Metal stent ; Uncovered metal stent
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.
Full Text
https://link.springer.com/article/10.1007%2Fs00464-016-5341-8
DOI
10.1007/s00464-016-5341-8
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Preventive Medicine and Public Health (예방의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Nam, Jung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Hyun Jik(이현직)
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/160335
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