NCT00721175

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Detailed description

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 months). 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.

Conditions

• Hilar Cholangiocarcinoma

Interventions

Type	Name	Description
DEVICE	biliary stent (self expandable metallic stent)	metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
DEVICE	PS	plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-04-01
• Completion: 2010-09-01
• First posted: 2008-07-23
• Last updated: 2011-12-23
• Results posted: 2011-12-23

Locations

1 site across 1 country: Thailand