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

Unresectable Hilar Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00746538
• Other study ID #: HE500636(subproject)
• Secondary ID: HE5OO636(sub)
• Status: Recruiting
• Phase: Phase 4
• First received: September 3, 2008
• Last updated: September 3, 2008
• Start date: January 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2008
• Source: Khon Kaen University
• Contact: Worrarat Kongkasame, MD
• Phone: (66)0817259376
• Email: worrarat-eab[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Klatskin's Tumor
• Unresectable Hilar Cholangiocarcinoma

Intervention

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

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital.KhonKaen University.	Muang	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.		2-4 weeks	No
Secondary	To assessment of early and late complication after palliative stent.		After stent insertion for sixth month and one year or until patients were expired	No
Secondary	Survival rate at sixth month and one year.		After stent insertion for sixth month and one year or until patients were expired	No