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


Phase 4
18 Years
N/A
Not Enrolling
Both
Hilar Cholangiocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

at 2 weeks and 4 weeks after stent insertion

Safety Issue:

No

Principal Investigator

apichat sangchan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medicine. Faculty of Medicine. KhonKaen University

Authority:

Thailand: Khon Kaen University Ethics Committee for Human Research

Study ID:

HE500636

NCT ID:

NCT00721175

Start Date:

November 2007

Completion Date:

September 2010

Related Keywords:

  • Hilar Cholangiocarcinoma
  • biliary stent
  • plastic stent
  • metallic stent
  • Complex hilar cholangiocarcinoma (Bismuth type II,III,IV)
  • Cholangiocarcinoma
  • Klatskin's Tumor

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