Photodynamic Therapy for Cholangiocarcinoma

Evaluation of Bile Duct Patency After Photodynamic Therapy in Unresectable Cholangiocarcinoma：a Prospective Non-randomized Controlled Study

Comparison of the bile duct patency with photodynamic therapy (PDT) and regular Endoscopic Retrograde Cholangiopancreatography(ERCP) stents in unresectable cholangiocarcinoma.

Cholangiocarcinoma is a malignant tumor originating from the bile duct epithelium, accounting for about 70% of the malignant tumors of the bile duct system. Patients have no obvious clinical symptoms in the early stage. After late diagnosis, the effective treatment is surgical resection and & or liver transplantation, and chemotherapy is only used as adjuvant or palliative treatment. Some types of cholangiocarcinomas, such as hilar cholangiocarcinomas, are difficult to achieve radical resection due to their anatomical location, early invasions and are prone to recurrence with a poor long-term efficacy after surgery. Therefore, the comprehensive treatment of cholangiocarcinoma by multiple means urgently needs to be explored. In recent years, photodynamic therapy (PDT), as a new local treatment method, has attracted increasing attention.

This study investigates the bile duct patency and effectiveness of photodynamic therapy compare with ordinary ERCP treatment for cholangiocarcinoma including the median survival, overall survival, and other indicators of side effects.

Inclusion Criteria:

• ERCP cholangiocarcinoma（the tumor is unresectable or patient can't accept surgery in the situation, the tumor can be resected but the patients cannot tolerate surgery）;

Exclusion Criteria:

• Proximal cholangiocarcinoma (Bismuth type Ⅲ-Ⅳ, or intra-hepatic cholangiocarcinoma);
• Patients with Karnofsky Performance Scale (KPS) score≤70；
• Expected survival≤3months；
• Patients with porphyria；
• Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count(<50×10^9 / L) or using anti-coagulation drugs；
• Bilirubin could not be reduced to less than 100mmol/L within 1 month after drainage；
• Patients have intrahepatic metastasis or distant metastasis；
• Patients with no pathological diagnosis；
• known to allergic to study drug(porphyrin drugs) or other similar and related compounds；
• Other photosensitizers have been used within 4 weeks prior；
• Metal biliary stents were placed previously；
• Patients with contraindications to ERCP；
• Patients with HIV infection；
• Pregnant, parturient, or breastfeeding women；
• Patients complicated with other malignant tumors；
• Patients with severe liver function damage；
• Patients who were in cachexia, liver abscess, or advanced patients who were unable to tolerate PDT；
• Patients with other serious physical or mental illnesses that prevent researchers to enroll them in this study as subjects；
• Patients with other contraindications for photodynamic therapy.