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

NCT ID: NCT00746538

Last Updated: 2008-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-07-31

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:

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.

Conditions

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Unresectable Hilar Cholangiocarcinoma

Keywords

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Hilar cholangiocarcinoma biliary stent plastic stent metallic stent quality of life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

metallic stent group

Group Type EXPERIMENTAL

biliary stent

Intervention Type DEVICE

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

2

plastic stent group

Group Type ACTIVE_COMPARATOR

biliary stent

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Self expandable metallic stent Amsterdam type plastic stent

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Department of Medice. Faculty of Medicine. Khonkaen University

Principal Investigators

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Worrarat Kongkasame, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine.Faculty of Medicine .KhonKaen University

Locations

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Srinagarind Hospital.KhonKaen University.

Muang, KhonKaen, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Worrarat Kongkasame, MD

Role: CONTACT

Phone: (66)0817259376

Email: [email protected]

References

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De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3. doi: 10.1067/mge.2003.310.

Reference Type RESULT
PMID: 12838220 (View on PubMed)

Related Links

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http://www.md.kku.ac.th/research/index.php?

Research affairs.Faculty of Medicine.KhonKaen University

Other Identifiers

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HE5OO636(sub)

Identifier Type: -

Identifier Source: secondary_id

HE500636(subproject)

Identifier Type: -

Identifier Source: org_study_id