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

Khon Kaen University

Status and phase: Unknown; Phase 4

Conditions: Unresectable Hilar Cholangiocarcinoma

Treatments: Device: biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00746538

HE500636(subproject)

HE5OO636(sub)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Exclusion criteria

• Patient with ASA 4 or 5
• Patient who inability to comply with follow up
• Patient refused to join the research

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

metallic stent group

Treatment:

Device: biliary stent

2

Active Comparator group

Description:

plastic stent group

Treatment:

Device: biliary stent