Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Obstructive Jaundice
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Jaundice; Jaundice, Obstructive
Study type: Interventional

Summary: 
      The prognosis of patients with obstructive jaundice caused by hepatocellular carcinoma (HCC)
      is dismal even after biliary drainage; due to malfunction of the biliary drainage tube caused
      by hemobilia and/or tumor emboli. Photodynamic therapy (PDT) in hilar cholangiocarcinoma
      improves biliary drainage and prolongs survival. The aims of this study were to assess the
      safety and efficacy of PDT in unresectable HCC with bile duct invasion.
    

Detailed description: 
      As more therapies are available for patients with hepatocellular carcinoma (HCC), the
      survival rate has improved. The incidence of jaundice in patients with HCC is reported as
      5-44%, and substantial number of patients experience obstructive jaundice. With the
      improvement of survival in patients with HCC, it is not uncommon to encounter HCC patients
      with obstructive jaundice in clinical practice.

      The prognosis of patients with obstructive jaundice caused by HCC is dismal due to
      progressive liver failure, rapid tumor progression and ineffective biliary drainage. The mean
      survival of HCC with obstructive jaundice after biliary drainage ranges from 2.5 to 4.5
      months. Effective biliary drainage to improve jaundice and liver function is inevitably
      needed for further treatment. However, it is difficult to maintain the patency of the bile
      duct because recurrent obstruction frequently develops due to hemobilia.

      Photodynamic therapy (PDT) with biliary drainage is a promising treatment option for advanced
      cholangiocarcinoma. Presence of the photosensitizer only itself is nontoxic, but showing
      light with specific wavelengths can induce cytotoxicity. The systemically administrated
      photosensitizer accumulates preferentially in proliferating tissue. If this targeted lesion
      is then illuminated by light of a specific wavelength, the activated photosensitizer
      generates reactive oxygen species, which trigger cell death by apoptosis and necrosis of the
      cells in the specific area. Experience with PDT in cholangiocarcinoma suggests that a
      survival benefit can be achieved by prolonged relief of the obstruction.

      The investigators hypothesized that conducting PDT with biliary stenting in patients with
      obstructive jaundice caused by bile duct invasion of HCC would improves stent patency and
      other clinical outcomes. The aim of this study was to evaluate the safety and efficacy of PDT
      in HCC patients with bile duct invasion.
    

Intervention name(s): Photofrin
Intervention type(s): Drug
Intervention description(s): Photodynamic therapy: Intravenous Photofrin at a dose of 2 mg/kg body weight, 48 hours before photoactivation by intraluminal light illumination
Other intervention name(s): Photofrin (Axcan Pharma Inc., Mount-Saint-Hilaire, Canada)
Intervention MeSH terms: Dihematoporphyrin Ether; Hematoporphyrin Derivative; Trioxsalen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular carcinoma; Obstructive jaundice; Photodynamic therapy