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Completed

NCT Number: NCT00721175

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

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.

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Key information

Conditions

Hilar Cholangiocarcinoma Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Srinagarind Hospital. KhonKaen University.

Muang, KhonKaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biliary stent (self expandable metallic stent)

Device

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

Other names: self expandable metallic stent

PS

Device

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

Other names: Amsterdam type plastic stent

Primary outcomes

  1. Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)

    Time frame: at 2 weeks and 4 weeks after stent insertion

    Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.

  2. Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)

    Time frame: at 2 weeks and 4 weeks after stent insertion

    Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.

Secondary outcomes

  1. Patients Survival Times

    Time frame: until patient died or 6 months after the last patient was enrolled

    survival times of the patients after the first stent insertion

  2. Cost Effective Ratio of Metallic and Plastic Stent

    Time frame: until the patients expire (Markov model)

    cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 23, 2008
Registry last updated
Dec 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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