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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00746538
Enrollment
80
Registered
2008-09-04
Start date
2008-01-31
Completion date
2009-07-31
Last updated
2008-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Hilar Cholangiocarcinoma

Keywords

Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life

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.

Interventions

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

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime 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

Countries

Thailand

Contacts

Primary ContactWorrarat Kongkasame, MD
worrarat-eab@hotmail.com(66)0817259376

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026