Clinical trial NCT00746538: Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent
Official title: Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Unresectable Hilar Cholangiocarcinoma
Keywords: Hilar cholangiocarcinoma
biliary stent
plastic stent
metallic stent
quality of life
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2008-09-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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 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

Primary outcomes:
measure: To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
timeFrame: 2-4 weeks
Secondary outcomes:
measure: To assessment of early and late complication after palliative stent.
timeFrame: After stent insertion for sixth month and one year or until patients were expired
measure: Survival rate at sixth month and one year.
timeFrame: After stent insertion for sixth month and one year or until patients were expired
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Srinagarind Hospital.KhonKaen University.
state: KhonKaen
Study officials:
affiliation: Department of Medicine.Faculty of Medicine .KhonKaen University
name: Worrarat Kongkasame, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1067/mge.2003.310.