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

Overview

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.

Full Title of Study: “Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2010

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: SEMS
    • self-expandable metal stent group
  • Active Comparator: PS
    • plastic stent group

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Khon Kaen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Apichat Sangchan, Assist. Prof. – Khon Kaen University
  • Overall Official(s)
    • apichat sangchan, MD, Principal Investigator, Department of Medicine. Faculty of Medicine. KhonKaen University

References

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.

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