NCT01739465
Unknown
Phase 2
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Guangzhou Medical University2 sites in 1 country120 target enrollmentNovember 2012
ConditionsCholangiocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cholangiocarcinoma
- Sponsor
- Guangzhou Medical University
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- stent patency
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma
Investigators
Huihong Liang
Associated Professor
Guangzhou Medical University
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
Outcomes
Primary Outcomes
stent patency
Time Frame: 6 months
Secondary Outcomes
- overall survival rate(3 years)
Study Sites (2)
Loading locations...
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