Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

October 23, 2015 updated by: Werner Dolak, MD, Medical University of Vienna

Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction - a Retrospective Analysis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Photodynamic therapy
Patients who underwent photodynamic therapy for malignant biliary obstruction.
Procedure: Photodynamic therapy using polyhematoporphyrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of photodynamic therapy
Time Frame: 30 days
Treatment emergent adverse events
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of first photodynamic therapy until date of death from any cause, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Werner Dolak, M.D., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 19, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 1448/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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