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

Tracking Information

First Received Date ^ICMJE

September 3, 2008

Last Updated Date

September 3, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Unresectable Hilar Cholangiocarcinoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
metallic stent group

Intervention: Device: biliary stent
Active Comparator: 2
plastic stent group

Intervention: Device: biliary stent

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Worrarat Kongkasame, MD

(66)0817259376

worrarat-eab@hotmail.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00746538

Other Study ID Numbers ^ICMJE

HE500636(subproject), HE5OO636(sub)

Has Data Monitoring Committee

Responsible Party

Worrarat Kongkasame, Department of Medice. Faculty of Medicine. Khonkaen University

Study Sponsor ^ICMJE

Khon Kaen University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Worrarat Kongkasame, MD

Department of Medicine.Faculty of Medicine .KhonKaen University

Information Provided By

Khon Kaen University

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top