Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00746538

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 IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial

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
1: Experimental 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
2: Active Comparator 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

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:

plastic stent made from polyethylene or polytetrafluoroethylene
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746538

Contacts

Contact: Worrarat Kongkasame, MD

(66)0817259376

worrarat-eab@hotmail.com

Locations

Thailand, KhonKaen
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

Research affairs.Faculty of Medicine.KhonKaen University This link exits the ClinicalTrials.gov site

Publications of Results:

De Palma GD, Pezzullo A, Rega M, Persico M, Patrone F, Mastantuono L, Persico G. Unilateral placement of metallic stents for malignant hilar obstruction: a prospective study. Gastrointest Endosc. 2003 Jul;58(1):50-3.

Responsible Party:	Department of Medice. Faculty of Medicine. Khonkaen University ( Worrarat Kongkasame )
Study ID Numbers:	HE500636(subproject), HE5OO636(sub)
Study First Received:	September 3, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746538
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

Study placed in the following topic categories:

Cholangiocarcinoma
Quality of Life
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009