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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01506115

First received: December 29, 2011

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2011

Last Updated Date

January 18, 2012

Start Date ^ICMJE

September 2009

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01506115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatocellular Carcinoma
Obstructive Jaundice

Intervention ^ICMJE

Drug: Photofrin

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)

Study Arm (s)

Experimental: HCC with bile duct invasion

Photodynamic therapy with biliary drainage in patients with bile duct invasion of unresectable HCC

Intervention: Drug: Photofrin

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01506115

Other Study ID Numbers ^ICMJE

2009-09-048

Has Data Monitoring Committee

Yes

Responsible Party

Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Kwang Hyuck Lee, M.D.

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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