Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00721175

Purpose

To compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis

Condition	Intervention	Phase
Cholangiocarcinoma	Device: biliary stent (self expandable metallic stent) Device: biliary stent ( Amsterdam type plastic stent)	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

Adequacy of biliary drainage of metallic stent compare to plastic stent group. [ Time Frame: 2-4 weeks after stent insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cost comparison [ Time Frame: until the patients expire or 6 months after stent insertion of the last patient in this study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental metallic stent group	Device: biliary stent (self expandable metallic stent) metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP
2: Active Comparator plastic stent group	Device: biliary stent ( Amsterdam type plastic stent) plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

Detailed Description:

There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (~3-9 months).

Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Unresectable complex hilar cholangiocarcinoma which diagnosis and staging based on computed tomography(CT) or magnetic resonance cholangiopancreatography (MRCP)

Exclusion Criteria:

Patients with ASA 4 or 5
Patients with liver failure.
Patients unable to comply with follow-up

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721175

Contacts

Contact: apichat sangchan, MD

(66)850004651

apichaz@yahoo.com

Locations

Thailand, KhonKaen
Srinagarind Hospital. KhonKaen University.	Recruiting
Muang, KhonKaen, Thailand, 40002
Contact: apichat sangchan, MD (66)850004651 apichaz@yahoo.com
Principal Investigator: apichat sangchan, MD

Sponsors and Collaborators

Khon Kaen University

Investigators

Principal Investigator:

apichat sangchan, MD

Department of Medicine. Faculty of Medicine. KhonKaen University

More Information

Research affairs. Faculty of Medicine. KhonKaen University This link exits the ClinicalTrials.gov site

KhonKaen University Ethics Committee for Human Research This link exits the ClinicalTrials.gov site

This study is the part of research project of Liver and Cholangiocarcinoma Research Center in year 2007 This link exits the ClinicalTrials.gov site

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.

Wagner HJ, Knyrim K, Vakil N, Klose KJ. Plastic endoprostheses versus metal stents in the palliative treatment of malignant hilar biliary obstruction. A prospective and randomized trial. Endoscopy. 1993 Mar;25(3):213-8.

Freeman ML, Overby C. Selective MRCP and CT-targeted drainage of malignant hilar biliary obstruction with self-expanding metallic stents. Gastrointest Endosc. 2003 Jul;58(1):41-9.

Responsible Party:	Department of Medicine. Faculty of Medicine. KhonKaen University ( apichat sangchan )
Study ID Numbers:	HE500636
Study First Received:	July 21, 2008
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00721175
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

hilar cholangiocarcinoma
biliary stent
plastic stent
metallic stent

Study placed in the following topic categories:

Cholangiocarcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009