Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent

Study Overview
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Brief Summary
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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
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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: plastic stent made from polyethylene or polytetrafluoroethylene 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.

Official Title
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Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial

Conditions
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Unresectable Hilar Cholangiocarcinoma

Intervention / Treatment
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* Device: biliary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patient with ASA 4 or 5 Patient who inability to comply with follow up Patient refused to join the research

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>metallic stent group | Device: biliary stent<br>* Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP<br>* Other names: Amsterdam type plastic stent;|
| Active Comparator: 2<br>plastic stent group | Device: biliary stent<br>* Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP<br>* Other names: Amsterdam type plastic stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. |  | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life