Brief Title
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
Official Title
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Brief Summary
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
stent patency
Secondary Outcome
overall survival rate
Condition
Cholangiocarcinoma
Intervention
Self expanding metallic stent (SEMS)
Study Arms / Comparison Groups
Self expanding metallic stent (SEMS )placement only
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
120
Start Date
November 2012
Primary Completion Date
December 2015
Eligibility Criteria
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
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, +86-20-34153043, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01739465
Organization ID
RFA2012
Responsible Party
Principal Investigator
Study Sponsor
Guangzhou Medical University
Study Sponsor
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Verification Date
February 2013