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

doi:10.1055/s-2003-44601

Endoscopy 2003; 35(12): 992-997
DOI: 10.1055/s-2003-44601

Original Article

A Prospective, Randomized Multicenter Trial Comparing DoubleLayer and Polyethylene Stents for Malignant Distal Common Bile Duct Strictures

A. Tringali¹ , M. Mutignani¹ , V. Perri¹ , G. Zuccalà² , L. Cipolletta³ , M. A. Bianco³ , G. Rotondano³ , M. Philipper⁴ , B. Schumacher⁴ , H. Neuhaus⁴ , A. Schmit⁵ , J. Devière⁵ , G. Costamagna¹

¹ Digestive Endoscopy Unit, Catholic University, Rome, Italy
² Dept. of Gerontology, Catholic University, Rome, Italy
³ Gastroenterology Unit, P.O. Maresca, Torre del Greco, Italy
⁴ Dept. of Internal Medicine, Evangelisches Krankenhaus, Düsseldorf, Germany
⁵ Dept. of Gastroenterology and Hepatopancreatology, Erasmus University Hospital, Brussels, Belgium

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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G. Costamagna, M.D.

Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, A. Gemelli University Hospital

Largo A. Gemelli 8 · 00168 Rome · Italy

Fax: +39-06-3551-1515

eMail: gcostamagna@rm.unicatt.it