Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial
There are two types of biliary stents: 1) the plastic stent made from polyethylene or
polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from
surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm.
The main drawback of the plastic stent is the relatively high occlusion rate, but its
advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical
advantages: 1) the flexible open-mesh design should allow drainage of secondary duct
branches; and, 2) its larger diameter may provide better drainage and longer patency (~3-9
Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness
remains undefined. Therefore, we would conduct this study to assess the efficacy of
drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in
unresectable, complex, hilar cholangiocarcinoma patients.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)
Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.
at 2 weeks and 4 weeks after stent insertion
apichat sangchan, MD
Department of Medicine. Faculty of Medicine. KhonKaen University
Thailand: Khon Kaen University Ethics Committee for Human Research