Observational Study for Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complications associated with the procedure
Procedure related cholangitis: fever accompanied by biliary pain that developed within three days after PDT without other infection Procedure related pancreatitis: abdominal pain and increases in amylase and lipase levels threefold higher than normal Procedure related bleeding: more than a 5% decrease in hematocrit compared to the initial value and coexisting bleeding on abdominal CT or endoscopy Complications associated with the photosensitizer: classified as photosensitivity, burn, and pigmentation
Kwang Hyuck Lee, M.D.
Samsung Medical Center
South Korea: Institutional Review Board