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

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ClinicalTrials.gov Identifier: NCT00746538
Recruitment Status : Unknown
Verified July 2008 by Khon Kaen University.
Recruitment status was:  Recruiting
First Posted : September 4, 2008
Last Update Posted : September 4, 2008
Sponsor:
Information provided by:
Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Unresectable Hilar Cholangiocarcinoma Device: biliary stent Phase 4

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
Study Start Date : January 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • Self expandable metallic stent
  • Amsterdam type plastic 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:
  • Self expandable metallic stent
  • Amsterdam type plastic stent



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

Secondary Outcome Measures :
  1. 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 ]
  2. Survival rate at sixth month and one year. [ Time Frame: After stent insertion for sixth month and one year or until patients were expired ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746538


Contacts
Contact: Worrarat Kongkasame, MD (66)0817259376 worrarat-eab@hotmail.com

Locations
Thailand
Srinagarind Hospital.KhonKaen University. Recruiting
Muang, KhonKaen, Thailand
Principal Investigator: Worrarat Kongkasame, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Worrarat Kongkasame, MD Department of Medicine.Faculty of Medicine .KhonKaen University

Publications:
Responsible Party: Worrarat Kongkasame, Department of Medice. Faculty of Medicine. Khonkaen University
ClinicalTrials.gov Identifier: NCT00746538     History of Changes
Other Study ID Numbers: HE500636(subproject)
HE5OO636(sub)
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: September 4, 2008
Last Verified: July 2008

Keywords provided by Khon Kaen University:
Hilar cholangiocarcinoma
biliary stent
plastic stent
metallic stent
quality of life

Additional relevant MeSH terms:
Cholangiocarcinoma
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms