Trial Information
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
stent patency
Outcome Time Frame:
6 months
Safety Issue:
No
Authority:
China: Science and Technology Commission of Guangzhou
Study ID:
RFA2012
NCT ID:
NCT01739465
Start Date:
November 2012
Completion Date:
Related Keywords:
- Cholangiocarcinoma
- Cholangiocarcinoma
- Pathologic
- Digestive System
- Neoplasms
- Neoplasms by Site
- Digestive System Diseases
- Bile Duct Diseases
- Biliary Tract Diseases
- Pathological Conditions
- Constriction
- Adenocarcinoma
- Carcinoma
- Cholangiocarcinoma