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NCT01739465 Clinical Trial

Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01739465
Other study ID # RFA2012
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received November 29, 2012
Last updated February 25, 2013
Start date November 2012

Study information
Verified date February 2013
Source Guangzhou Medical University
Contact Huihong Liang, MD
Phone +86-20-34153043
Email beanth@163.com
Is FDA regulated No
Health authority China: Science and Technology Commission of Guangzhou
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China The Second Hospital of Guangzhou Medical College Guangzhou Guangdong
China The second hospital of Guangzhou Medical college Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary stent patency 6 months No
Secondary overall survival rate 3 years No
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