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NCT Number: NCT02504957

Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

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.

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Key information

Conditions

Klatskin's Tumor Adenocarcinoma Carcinoma Cholangiocarcinoma Klatskin Tumor Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Photodynamic therapy using polyhematoporphyrin

Procedure

Primary outcomes

  1. Safety of photodynamic therapy

    Time frame: 30 days

    Treatment emergent adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2015
Registry last updated
Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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