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

NCT00746538 | Unknown Phase 4

• 2 other identifiers: HE500636(subproject)HE5OO636(sub)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable Hilar Cholangiocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  2-4 weeks

Secondary Outcomes (2)

• To assessment of early and late complication after palliative stent.

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

• Survival rate at sixth month and one year.

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

Study Arms (2)

1

EXPERIMENTAL

metallic stent group

Device: biliary stent

2

ACTIVE COMPARATOR

plastic stent group

Device: biliary stent

Interventions

biliary stent DEVICE

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

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind Hospital.KhonKaen University.

Muang, KhonKaen, Thailand

RECRUITING

Related 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. doi: 10.1067/mge.2003.310.

  PMID: 12838220 RESULT

Related Links

• Research affairs.Faculty of Medicine.KhonKaen University

MeSH Terms

Conditions

Klatskin Tumor

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Worrarat Kongkasame, MD

  Department of Medicine.Faculty of Medicine .KhonKaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Worrarat Kongkasame, MD

CONTACT

(66)0817259376; worrarat-eab@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 4, 2008

Record last verified: 2008-07

Locations

TH (1)