Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent
- Conditions
- Unresectable Hilar Cholangiocarcinoma
- Interventions
- Device: biliary stent
- Registration Number
- NCT00746538
- Lead Sponsor
- Khon Kaen University
- Brief Summary
The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.
- Detailed Description
In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
There are two types of biliary stent:
1. plastic stent made from polyethylene or polytetrafluoroethylene
2. metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
- Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
- Patient with ASA 4 or 5
- Patient who inability to comply with follow up
- Patient refused to join the research
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 biliary stent metallic stent group 2 biliary stent plastic stent group
- Primary Outcome Measures
Name Time Method To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. 2-4 weeks
- Secondary Outcome Measures
Name Time Method To assessment of early and late complication after palliative stent. After stent insertion for sixth month and one year or until patients were expired Survival rate at sixth month and one year. After stent insertion for sixth month and one year or until patients were expired
Trial Locations
- Locations (1)
Srinagarind Hospital.KhonKaen University.
🇹🇭Muang, KhonKaen, Thailand