Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

Not Applicable

Completed

• Conditions: Klatskin's Tumor
• Interventions: Procedure: Photodynamic therapy using polyhematoporphyrin

• Registration Number: NCT02504957
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic therapy	Photodynamic therapy using polyhematoporphyrin	Patients who underwent photodynamic therapy for malignant biliary obstruction.

Primary Outcome Measures

Name	Time	Method
Safety of photodynamic therapy	30 days	Treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy of photodynamic therapy	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