A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Charlton 8, GI Endoscopy, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA.
Gastroenterology Research and Practice (Impact Factor: 1.5). 03/2013; 2013:642428. DOI: 10.1155/2013/642428
Source: PubMed

ABSTRACT Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.

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    ABSTRACT: Background Covered metallic stents (CMSs) were developed to overcome tumor ingrowth in uncovered metallic stents (UMSs) for malignant biliary obstruction, but superiority of CMSs over UMSs is still controversial due to the high migration rate in CMS. Therefore, we conducted this retrospective analysis to clarify risk factors for stent migration including mechanical properties of CMSs.Methods Patients with unresectable pancreatic cancer, receiving CMS for distal malignant biliary obstruction in 5 tertiary care centers, were retrospectively studied. Univariate and multivariate analyses to identify prognostic factors for early (<6 months) stent migration were performed using a proportional hazards model with death or stent occlusion without stent migration as a competing risk. Two mechanical properties were included in the analysis: axial force (AF), the recovery force that leads to a CMS straightening, and radial force (RF), the expansion force against the stricture.ResultsAmong 290 patients who received CMS placement for distal malignant biliary obstruction, stent migration rate was 15.2%. CMS migrated early (<6 months) in 10.0% and distally in 11.7%, respectively. In the multivariate analysis, significant risk factors for early stent migration were chemotherapy (subdistribution hazard ratios [SHR] 4.46, p = 0.01), CMS with low RF (SHR 2.23, p = 0.03) and duodenal invasion (SHR 2.25, p = 0.02).ConclusionCMS with low RF, chemotherapy and duodenal invasion were associated with CMS migration from our study.
    Journal of Gastroenterology and Hepatology 04/2014; DOI:10.1111/jgh.12602 · 3.33 Impact Factor

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