CClinicalTrials.gg
Status unknownNCT00746538Updated Sep 4, 2008

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

A Phase 4 interventional study of biliary stent in Unresectable Hilar Cholangiocarcinoma, sponsored by Khon Kaen University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-04.

Sponsored by Khon Kaen University · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unresectable Hilar Cholangiocarcinoma

Keywords

  • Hilar cholangiocarcinoma
  • biliary stent
  • plastic stent
  • metallic stent
  • quality of life
03

In context

Cholangiocarcinoma

914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.

Browse Cholangiocarcinoma studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient with ASA 4 or 5
  • Patient who inability to comply with follow up
  • Patient refused to join the research
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    1

    metallic stent group

    Device: biliary stent

  • Active comparator
    2

    plastic stent group

    Device: biliary stent

Interventions

  • Devicebiliary stent

    Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

    Also known as: Self expandable metallic stent, Amsterdam type plastic stent

06

What researchers measure

Primary outcomes

  1. To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.

    Time frame: 2-4 weeks

Secondary outcomes

  1. 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

  2. Survival rate at sixth month and one year.

    Time frame: After stent insertion for sixth month and one year or until patients were expired

07

Study locations

1 of 1 sites recruiting
  • Srinagarind Hospital.KhonKaen University.
    Muang, KhonKaen, Thailand
    • Worrarat Kongkasame, MD · Principal investigator
    Recruiting
08

References and documents

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. doi: 10.1067/mge.2003.310. PubMed 12838220 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00746538
Lead sponsor
Khon Kaen University
First posted
Sep 4, 2008
Start date
Jan 2008
Primary completion
Mar 2009 (estimated)
Completion
Jul 2009 (estimated)
Last update
Sep 4, 2008

Study contacts

Worrarat Kongkasame, MD
Contact
worrarat-eab@hotmail.com
(66)0817259376
Worrarat Kongkasame, MD
principal investigator · Department of Medicine.Faculty of Medicine .KhonKaen University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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