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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Khon Kaen University

Current Primary Outcome: To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. [ Time Frame: 2-4 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assessment of early and late complication after palliative stent. [ Time Frame: After stent insertion for sixth month and one year or until patients were expired ]
  • Survival rate at sixth month and one year. [ Time Frame: After stent insertion for sixth month and one year or until patients were expired ]


Original Secondary Outcome: Same as current

Information By: Khon Kaen University

Dates:
Date Received: September 3, 2008
Date Started: January 2008
Date Completion: July 2009
Last Updated: September 3, 2008
Last Verified: July 2008