Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
NCT ID: NCT01739465
Last Updated: 2013-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Self expanding metallic stent (SEMS)
Self expanding metallic stent
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
Self expanding metallic stent (SEMS)
Self expanding metallic stent
Endoscopic radiofrequency ablation (ERFA)
Endoscopic radiofrequency ablation
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
Self expanding metallic stent (SEMS)
Self expanding metallic stent
Photodynamic therapy (PDT)
Photodynamic therapy
Interventions
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Self expanding metallic stent (SEMS)
Self expanding metallic stent
Endoscopic radiofrequency ablation (ERFA)
Endoscopic radiofrequency ablation
Photodynamic therapy (PDT)
Photodynamic therapy
Eligibility Criteria
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Inclusion Criteria
* Pathologically or radiologically confirmed biliary malignant
* Inoperability by staging
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Guangzhou Medical University
OTHER
Responsible Party
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Huihong Liang
Associated Professor
Locations
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The Second Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
The second hospital of Guangzhou Medical college
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RFA2012
Identifier Type: -
Identifier Source: org_study_id
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