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

Sponsor

Khon Kaen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00746538

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Hilar Cholangiocarcinoma	Device: biliary stent	Phase 4

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jan 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2009

Anticipated Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 metallic stent group	Device: biliary stent Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP Other Names: Self expandable metallic stent Amsterdam type plastic stent
Active Comparator: 2 plastic stent group	Device: biliary stent Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP Other Names: Self expandable metallic stent Amsterdam type plastic stent

Arm

Intervention/Treatment

Experimental: 1

metallic stent group

Device: biliary stent

Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Other Names:

Self expandable metallic stent

Amsterdam type plastic stent

Active Comparator: 2

plastic stent group

Device: biliary stent

Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Other Names:

Self expandable metallic stent

Amsterdam type plastic stent

Outcome Measures

Primary Outcome Measures

To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. [2-4 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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