Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Observational Study for Safety and Efficacy of Photodynamic Therapy for Bile Duct Invasion of Hepatocellular Carcinoma|
- Complications associated with the procedure [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
- 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
- Improvement of jaundice [ Time Frame: Six months ] [ Designated as safety issue: No ]The improvement of jaundice was defined as a decrease in total bilirubin by more than 30% of the pre-procedural value.
- Disappearance of hemobilia [ Time Frame: Six months ] [ Designated as safety issue: No ]Disappearance of hemobilia was defined when there was no more evidence of bleeding in patients with previous hemobilia after PDT.
- Survival time [ Time Frame: Six months ] [ Designated as safety issue: No ]Survival time was defined as the duration from the date of imaging showing bile duct invasion of HCC to the date of death or to the last follow-up.
|Study Start Date:||September 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: HCC with bile duct invasion
Photodynamic therapy with biliary drainage in patients with bile duct invasion of unresectable HCC
Photodynamic therapy: Intravenous Photofrin at a dose of 2 mg/kg body weight, 48 hours before photoactivation by intraluminal light illumination
Other Name: Photofrin (Axcan Pharma Inc., Mount-Saint-Hilaire, Canada)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506115
|Korea, Republic of|
|Samsung Medical Center 81 Irwon-Ro Gangnamgu|
|Seoul, Korea, Republic of, 06351|
|Study Director:||Kwang Hyuck Lee, M.D.||Samsung Medical Center|