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Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

NCT ID: NCT00721175

Last Updated: 2011-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

Detailed Description

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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.

Conditions

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Hilar Cholangiocarcinoma

Keywords

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biliary stent plastic stent metallic stent Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SEMS

self-expandable metal stent group

Group Type EXPERIMENTAL

biliary stent (self expandable metallic stent)

Intervention Type DEVICE

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

PS

plastic stent group

Group Type ACTIVE_COMPARATOR

PS

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

PS

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

Intervention Type DEVICE

Other Intervention Names

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self expandable metallic stent Amsterdam type plastic stent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Apichat Sangchan

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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apichat sangchan, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine. Faculty of Medicine. KhonKaen University

Locations

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Srinagarind Hospital. KhonKaen University.

Muang, KhonKaen, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 12838220 (View on PubMed)

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. doi: 10.1055/s-2007-1010295.

Reference Type BACKGROUND
PMID: 7686100 (View on PubMed)

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. doi: 10.1067/mge.2003.292.

Reference Type BACKGROUND
PMID: 12838219 (View on PubMed)

Sangchan A, Kongkasame W, Pugkhem A, Jenwitheesuk K, Mairiang P. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15.

Reference Type DERIVED
PMID: 22595446 (View on PubMed)

Related Links

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http://eckku.kku.ac.th/

KhonKaen University Ethics Committee for Human Research

Other Identifiers

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HE500636

Identifier Type: -

Identifier Source: org_study_id