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

Phase 4

Completed

• Conditions: Hilar Cholangiocarcinoma
• Interventions: Device: biliary stent (self expandable metallic stent); Device: PS

• Registration Number: NCT00721175
• Lead Sponsor: Khon Kaen University

Brief 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-21
• Study First Submitted QC: 2008-07-22
• Study First Posted: 2008-07-23
• Primary Completion: 2010-04
• Study Completion: 2010-09
• Results First Submitted: 2011-08-23
• Status Verified: 2011-11
• Results First Submitted QC: 2011-11-21
• Last Update Submitted: 2011-11-21
• Results First Posted: 2011-12-23
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria

• Patients with ASA 4 or 5
• Patients with liver failure.
• Patients unable to comply with follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEMS	biliary stent (self expandable metallic stent)	self-expandable metal stent group
PS	PS	plastic stent group

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)	at 2 weeks and 4 weeks after stent insertion	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.
Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)	at 2 weeks and 4 weeks after stent insertion	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.

Secondary Outcome Measures

Name	Time	Method
Cost Effective Ratio of Metallic and Plastic Stent	until the patients expire (Markov model)	cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature
Patients Survival Times	until patient died or 6 months after the last patient was enrolled	survival times of the patients after the first stent insertion

Trial Locations

Locations (1)

Srinagarind Hospital. KhonKaen University.; 🇹🇭 Muang, KhonKaen, Thailand