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Observational Study for Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma

19 Years
70 Years
Not Enrolling
Hepatocellular Carcinoma, Obstructive Jaundice

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Trial Information

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.

Inclusion Criteria:

- Known HCC: Diagnosis of HCC based on the 2005 AASLD (American Association for the
Study of Liver Diseases) practice guidelines

- Unresectable HCC: Determined based on the BCLC (Barcelona-Clinic-Liver-Cancer)
staging and treatment system

- Bile duct invasion of HCC: Confirmed by pathology via endoscopic retrograde
cholangiopancreatogram (ERCP) or percutaneous transhepatic biliary drainage (PTBD).
In case pathological diagnosis is clinically impossible, confirmed by dynamic CT or
MRI showing that typical arterial enhancing mass in dilated bile duct and previous
HCC diagnosis.

Exclusion Criteria:

- Severe renal disease

- Severe cardiac disease

- Bleeding tendency

- Porphyria

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complications associated with the procedure

Outcome Description:

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

Outcome Time Frame:

Six months

Safety Issue:


Principal Investigator

Kwang Hyuck Lee, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Samsung Medical Center


South Korea: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

March 2011

Related Keywords:

  • Hepatocellular Carcinoma
  • Obstructive Jaundice
  • Hepatocellular carcinoma
  • Obstructive jaundice
  • Photodynamic therapy
  • Carcinoma
  • Jaundice
  • Jaundice, Obstructive
  • Carcinoma, Hepatocellular