Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 40 for:    "Klatskin tumor"

Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02504957
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : October 26, 2015
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna

Brief Summary:
Photodynamic therapy (PDT) is a palliative treatment for malignant biliary obstruction. The aim of this study is to assess the feasibility and safety of this technique in the context of a nationwide retrospective analysis.

Condition or disease Intervention/treatment Phase
Klatskin's Tumor Procedure: Photodynamic therapy using polyhematoporphyrin Not Applicable

Detailed Description:

INTRODUCTION

Malignant biliary obstruction is a life threatening condition in patients suffering from primary or secondary bile duct malignancies. Palliative therapies aim to prevent complications associated with the obstruction. Photodynamic therapy (PDT) aims to reduce the local tumor mass by inducing tumor necrosis after light activation of a photosensitizer during endoscopic retrograde cholangiography (ERC).

STUDY AIMS

The aim of the present study is to evaluate the feasibility and safety of PDT with polyhematoporphyrin, the photosensitizer most commonly used for PDT in Austria, in the context of a nationwide analysis.

METHODS

This retrospective study will be conducted at seven Austrian referral centers for bilio-pancreatic endoscopy. The study protocol was approved by the internal review board of the Medical University of Vienna (EK 1448/2012). Patients who underwent PDT with polyhematoporphyrin as therapy for malignant biliary obstruction after 2004 will be identified using examination report databases. Examination reports and patient charts will be analyzed to assess underlying diseases, oncological co-therapies, intra-procedural adverse events, hospital stay, adverse events within 30 days post intervention as well as 30-day, 90-day, and overall mortality. All patient data will be de-identified using pseudonymization prior to any further processing. Descriptive statistics will be used to present the study parameters. Survival will be assessed using Kaplan-Meier statistics and compared between the different underlying tumor entities using the Log Rank test. Cox regression will be used to identify independent predictors of survival. Significant factors at univariate analysis will be entered into multivariate testing. P-values less than 0.05 will be considered significant. SPSS version 23.0 will serve for data analysis.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction - a Retrospective Analysis.
Study Start Date : July 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Photodynamic therapy
Patients who underwent photodynamic therapy for malignant biliary obstruction.
Procedure: Photodynamic therapy using polyhematoporphyrin



Primary Outcome Measures :
  1. Safety of photodynamic therapy [ Time Frame: 30 days ]
    Treatment emergent adverse events


Secondary Outcome Measures :
  1. Efficacy of photodynamic therapy [ Time Frame: From date of first photodynamic therapy until date of death from any cause, assessed up to 100 months ]
    Overall survival as surrogate marker of treatment efficacy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergone photodynamic therapy as a treatment for malignant biliary obstruction.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504957


Sponsors and Collaborators
Medical University of Vienna
Investigators
Layout table for investigator information
Principal Investigator: Werner Dolak, M.D. Medical University of Vienna

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Werner Dolak, MD, Assistant doctor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02504957     History of Changes
Other Study ID Numbers: EK 1448/2012
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Werner Dolak, MD, Medical University of Vienna:
Photodynamic therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Klatskin Tumor
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms