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

NCT01506115 | Completed DMC

• 1 other identifier: 2009-09-048
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Obstructive Jaundice

Keywords

Hepatocellular carcinoma; Obstructive jaundice; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Six months

Secondary Outcomes (3)

• Improvement of jaundice

  Six months

• Disappearance of hemobilia

  Six months

• Survival time

  Six months

Study Arms (1)

HCC with bile duct invasion

EXPERIMENTAL

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

Drug: Photofrin

Interventions

Photofrin DRUG

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)

HCC with bile duct invasion

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe renal disease
• Severe cardiac disease
• Bleeding tendency
• Porphyria

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center 81 Irwon-Ro Gangnamgu

Seoul, 06351, South Korea

Location

Related Publications (23)

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  PMID: 15844020 BACKGROUND

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Jaundice, Obstructive

Interventions

Dihematoporphyrin Ether

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors

Study Officials

• Kwang Hyuck Lee, M.D.

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 9, 2012
• Study Start: September 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 20, 2015

Record last verified: 2012-01

Locations

KR (1)