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

Primary Purpose

Unresectable Hilar Cholangiocarcinoma

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

biliary stent

About this trial

This is an interventional supportive care trial for Unresectable Hilar Cholangiocarcinoma focused on measuring Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Srinagarind Hospital.KhonKaen University.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

metallic stent group

plastic stent group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assessment of early and late complication after palliative stent.

Survival rate at sixth month and one year.

Full Information

NCT ID

NCT00746538

First Posted

September 3, 2008

Last Updated

September 3, 2008

Sponsor

Khon Kaen University

1. Study Identification

Unique Protocol Identification Number

NCT00746538

Brief Title

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

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Unknown status

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2009 (Anticipated)

Study Completion Date

July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Khon Kaen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unresectable Hilar Cholangiocarcinoma

Keywords

Hilar cholangiocarcinoma, biliary stent, plastic stent, metallic stent, quality of life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

metallic stent group

Arm Title

Arm Type

Active Comparator

Arm Description

plastic stent group

Intervention Type

Device

Intervention Name(s)

biliary stent

Other Intervention Name(s)

Self expandable metallic stent, Amsterdam type plastic stent

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2-4 weeks

Secondary Outcome Measure Information:

Title

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

Title

Survival rate at sixth month and one year.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Worrarat Kongkasame, MD

Phone

(66)0817259376

worrarat-eab@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Worrarat Kongkasame, MD

Organizational Affiliation

Department of Medicine.Faculty of Medicine .KhonKaen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Srinagarind Hospital.KhonKaen University.

City

Muang

State/Province

KhonKaen

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Worrarat Kongkasame, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

12838220

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.

Results Reference

result

Links:

URL

http://www.md.kku.ac.th/research/index.php?

Description

Research affairs.Faculty of Medicine.KhonKaen University

Learn more about this trial

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

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