Abstract:
BACKGROUND AND AIMS:Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. METHODS:This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. RESULTS:Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23). CONCLUSION:The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.).
journal_name
Gastrointest Endoscjournal_title
Gastrointestinal endoscopyauthors
Conio M,Mangiavillano B,Caruso A,Filiberti RA,Baron TH,De Luca L,Signorelli S,Crespi M,Marini M,Ravelli P,Conigliaro R,De Ceglie Adoi
10.1016/j.gie.2018.03.029subject
Has Abstractpub_date
2018-08-01 00:00:00pages
283-291.e3issue
2eissn
0016-5107issn
1097-6779pii
S0016-5107(18)30273-6journal_volume
88pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND AND AIMS:Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) rema...
journal_title:Gastrointestinal endoscopy
pub_type: 杂志文章
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journal_title:Gastrointestinal endoscopy
pub_type: 临床试验,杂志文章
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abstract:BACKGROUND:The Rockall scoring system was developed in unselected patients, the majority of whom did not receive endoscopic therapy. The aim of this study was to assess the validity of the Rockall system in high-risk patients who undergo endoscopic therapy for peptic ulcer hemorrhage. METHODS:Rockall scores were calcu...
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pub_type: 杂志文章,评审
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更新日期:1996-01-01 00:00:00
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pub_type: 杂志文章,多中心研究,随机对照试验
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pub_type: 临床试验,杂志文章,多中心研究
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