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


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.
Tringali
A
A
Digestive Endoscopy Unit, Catholic University, Rome, Italy.
Mutignani
M
M
Perri
V
V
Zuccalà
G
G
Cipolletta
L
L
Bianco
M A
MA
Rotondano
G
G
Philipper
M
M
Schumacher
B
B
Neuhaus
H
H
Schmit
A
A
Devière
J
J
Costamagna
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000150:complications; D003135:Common Bile Duct / Q000473:pathology*; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications; D020959:Polyethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents
D020959:Polyethylene