An interventional study of Photofrin in Hepatocellular Carcinoma and Obstructive Jaundice, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Photodynamic therapy with biliary drainage in patients with bile duct invasion of unresectable HCC
Drug: Photofrin
Photodynamic therapy: Intravenous Photofrin at a dose of 2 mg/kg body weight, 48 hours before photoactivation by intraluminal light illumination
Also known as: Photofrin (Axcan Pharma Inc., Mount-Saint-Hilaire, Canada)
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
Time frame: Six months
Improvement of jaundice
The improvement of jaundice was defined as a decrease in total bilirubin by more than 30% of the pre-procedural value.
Time frame: Six months
Disappearance of hemobilia
Disappearance of hemobilia was defined when there was no more evidence of bleeding in patients with previous hemobilia after PDT.
Time frame: Six months
Survival time
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.
Time frame: Six months
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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