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A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures.

A Tringali·M Mutignani·V Perri·G Zuccalà·L Cipolletta·M A Bianco·G Rotondano·M Philipper·B Schumacher·H Neuhaus·A Schmit·J Devière·G Costamagna
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Abstract

BACKGROUND AND STUDY AIMS: Endoscopic biliary stenting is an established treatment for malignant obstructive jaundice. Stent clogging continues to be a major problem with plastic stents. The aim of this study was to carry out a prospective comparison of two stents with different materials and shapes: the Olympus DoubleLayer stent (DLS; perfluoro alkoxy, without sideholes) and the standard polyethylene (PE) stent (with sideholes). PATIENTS AND METHODS: A total of 120 patients (70 women; mean age 71, range 36 - 91) with jaundice due to malignant strictures of the middle to distal third of the common bile duct were randomly assigned to receive either DLS (n = 60) or PE (n = 60) biliary stents. Patients with cholangitis, hemobilia, previous biliary drainage, hilar stricture, or ampullary cancer were excluded. RESULTS: In all, 28 DLS patients (47 %) and 17 PE stent patients (29 %) died without clinical evidence of stent occlusion after a mean of 114 and 105 days, respectively ( P < 0.05). Twenty-six DLS patients (43 %) and 38 PE stent patients (63 %) had symptoms of stent clogging after a mean of 144 and 99 days, respectively ( P < 0.05). Stent dysfunction (stent orifice impacted on the bile duct or duodenal wall, stent migration) was recorded in six DLS patients (10 %) and five PE patients (8 %) (n. s.). Kaplan-Meier analysis of DLS and PE stent clogging-free survival showed a significantly longer patency period with the DLS stents (P = 0.0005). CONCLUSIONS: These results show that DoubleLayer stents have a longer patency period than PE stents. Patients who received PE stents had a higher risk of stent occlusion (relative risk 3.05; 95 % CI, 1.57 - 5.89) before death than DLS patients.

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AdultAgedAged, 80 and overBiliary Tract NeoplasmsCommon Bile DuctConstriction, PathologicFemaleHumansJaundice, ObstructiveMaleMiddle AgedPancreatic NeoplasmsPolyethyleneProspective StudiesProsthesis DesignStentsClinical TrialComparative StudyJournal ArticleMulticenter StudyRandomized Controlled Trial

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A Tringali, M Mutignani, V Perri, G Zuccalà, L Cipolletta, M A Bianco, G Rotondano, M Philipper, B Schumacher, H Neuhaus, A Schmit, J Devière, G Costamagna. 2003. A prospective, randomized multicenter trial comparing DoubleLayer and polyethylene stents for malignant distal common bile duct strictures.. https://doi.org/10.1055/s-2003-44601

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