Clinical Effect and Safety of PDT and RFA for Unresectable EHCC
Condition: Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Study type: Interventional

Summary: 
      The prognosis of patients with advanced unresectable EHCC is very poor with a median survival
      of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and
      survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is
      by far the only modality that has shown to improve stent patency as well as over survival
      (OS) in patients with cholangiocarcinoma. In recent years, many studies have shown that
      endoscopic radiofrequency ablation (RFA) extends stent patency and possibly the survival of
      patients with malignant biliary obstruction. However, there are few reports comparing the
      clinical efficacy and advers event of these two endoscopic treatment.
    

Detailed description: 
      Extrahepatic cholangiocarcinoma (EHCC) originates from the hepatic hilar region to the lower
      common bile duct. The prognosis of patients with advanced unresectable EHCC is very poor with
      a median survival of 3 to 6 months. Active control of tumor growth is the key to extending
      stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic
      therapy (PDT) is by far the only modality that has shown to improve stent patency as well as
      over survival (OS) in patients with cholangiocarcinoma. In an attempt to improve stent
      patency placed for malignant biliary obstruction, enthusiasm for endoscopic retrograde
      cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has been increasing in
      recent years. The HABIBTM EndoHBP catheter is an endoscopic bipolar RFA catheter with proven
      safety and effectiveness for biliary RFA of cholangiocarcinoma. Many studies have shown that
      endoscopic RFA extends stent patency and possibly the survival of patients with malignant
      biliary obstruction. However, there are few reports comparing the clinical efficacy and
      advers event of these two endoscopic treatment.
    

Intervention name(s): Photodynamic therapy; radiofrequency ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visualradiography. The dilation catheter was then withdrawn to leavethe 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.
Other intervention name(s): PDT; RFA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: extrahepatic cholangiocarcinoma; Photodynamic therapy; radiofrequency ablation