Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
About this trial
This is an interventional treatment trial for Extrahepatic Cholangiocarcinoma focused on measuring Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed cholangiocarcinoma;
- unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound(EUS);
- No previous treatment;
- Adequate bone marrow and organ function (white blood cells>4.0×109/L, hemoglobin>90 g/L, and platelets>75×109/L, serum creatinine<2.0 mg/dl);
- A Karnofsky performance status (KPS) score ≥ 50;
- Signed written informed consent.
Exclusion Criteria:
- Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs;
- Coexistent with other malignant tumors;
- Pregnant or nursing women;
- Previous gastrointestinal diversion;
- Participation in another study during the month before enrollment in this study;
- Alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.
Sites / Locations
- Hangzhou First People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Photodynamic therapy(PDT)
Radiofrequency ablation(RFA)
RFA+PDT
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s.
An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. After that An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.