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

September 3, 2008 updated by: Khon Kaen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • KhonKaen
      • Muang, KhonKaen, Thailand
        • Recruiting
        • Srinagarind Hospital.KhonKaen University.
        • Principal Investigator:
          • Worrarat Kongkasame, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
metallic stent group
Device: 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
Other Names:
  • Amsterdam type plastic stent
  • Self expandable metallic stent
Active Comparator: 2
plastic stent group
Device: 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
Other Names:
  • Amsterdam type plastic stent
  • Self expandable metallic stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
After stent insertion for sixth month and one year or until patients were expired

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Worrarat Kongkasame, MD, Department of Medicine.Faculty of Medicine .KhonKaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

March 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

September 3, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

September 4, 2008

Last Update Submitted That Met QC Criteria

September 3, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE500636(subproject)
  • HE5OO636(sub)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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