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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Khon Kaen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00746538
First received: September 3, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention Phase
Unresectable Hilar Cholangiocarcinoma
Device: biliary stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent. [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Survival rate at sixth month and one year. [ Time Frame: After stent insertion for sixth month and one year or until patients were expired ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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)
Study First Received: September 3, 2008
Last Updated: September 3, 2008
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

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

ClinicalTrials.gov processed this record on July 28, 2014