Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in
      increasing the survival time, decreasing cholestasis and improving health-related quality of
      life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable
      cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the
      procedure.
    

Detailed description: 
      Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical
      course, and lack of definitive diagnostic criteria. It is often clinically silent with
      symptoms developing only in advanced disease. Surgical resection is the recommended curative
      intervention with only a minority of patients (10-20%) having potentially resectable tumors
      at time of diagnosis.

      Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through
      transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary
      decompression provides relief of cholangitis and improvement in quality of life, it does not
      improve survival.

      Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency
      by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen
      species. Several studies suggest PDT plus biliary stent placement may prolong survival (range
      of 360-630 days), reduce cholangitis, and improve the quality of life of patients with
      advanced disease. The aim of this study is to determine the effectiveness and safety of PDT
      with biliary stenting compared to biliary stenting alone in the palliative treatment of
      unresectable CCA in China.
    

Intervention name(s): PDT; stent
Intervention type(s): Device; Device
Intervention description(s): Patients with unresectable CCA are performed PDT with ERCP after porfimer sodium （chongqing ray high medical instrument co., LTD，Chongqing, China) i.v. at a dose of 2 mg/kg at 48 h.
PDT procedure: for light distribution, flexible cylindrical diffuser probes mounted on 400-mm quartz fibres with an active distal tip length of 2 cm （chongqing ray high medical instrument co., LTD，Chongqing, China) is used. The light source was a diode laser system with a maximum power output of 2 Wand a wavelength of 633.3 nm. The power emitted by the diffuser tip was calibrated to 400 mW/cm before PDT was administered using an integrating sphere power meter. The mean irradiation time was 452 s (range: 400-600 s), using a power density of 300-400 mW/cm and an energy dose of 180-200 J/cm (of diffuser length).; Patients with unresectable CCA are performed with ERCP, one or several plastic biliary stents (Boston Scientific Corporation, MA,USA) are inserted to ensure adequate decompression and bile drainage.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biliary duct carcinoma; Photodynamic therapy