Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Overview

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Full Title of Study: “A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Interventions

  • Procedure: Self expanding metallic stent (SEMS)
    • Self expanding metallic stent
  • Procedure: Endoscopic radiofrequency ablation (ERFA)
    • Endoscopic radiofrequency ablation
  • Procedure: Photodynamic therapy (PDT)
    • Photodynamic therapy

Arms, Groups and Cohorts

  • Active Comparator: Self expanding metallic stent (SEMS )placement only
    • Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
  • Experimental: Endoscopic radiofrequency ablation plus SEMS
    • Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
  • Experimental: Photodynamic therapy plus SEMS
    • Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing

Clinical Trial Outcome Measures

Primary Measures

  • stent patency
    • Time Frame: 6 months

Secondary Measures

  • overall survival rate
    • Time Frame: 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 18 years old
  • Pathologically or radiologically confirmed biliary malignant
  • Inoperability by staging

Exclusion Criteria

  • Cholangiocarcinoma with widespread metastasis
  • Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
  • Prior SEMS placement
  • Pregnancy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
  • Life expectancy < 3months

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Huihong Liang, Associated Professor – Guangzhou Medical University
  • Overall Contact(s)
    • Huihong Liang, MD, +86-20-34153043, beanth@163.com

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