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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Unresectable Hilar Cholangiocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.

Outcome Time Frame:

2-4 weeks

Safety Issue:

No

Principal Investigator

Worrarat Kongkasame, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medicine.Faculty of Medicine .KhonKaen University

Authority:

Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:

HE500636(subproject)

NCT ID:

NCT00746538

Start Date:

January 2008

Completion Date:

July 2009

Related Keywords:

  • Unresectable Hilar Cholangiocarcinoma
  • Hilar cholangiocarcinoma
  • biliary stent
  • plastic stent
  • metallic stent
  • quality of life
  • Cholangiocarcinoma
  • Klatskin's Tumor

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