Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction
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|ClinicalTrials.gov Identifier: NCT02504957|
Recruitment Status : Completed
First Posted : July 22, 2015
Last Update Posted : October 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Klatskin's Tumor||Procedure: Photodynamic therapy using polyhematoporphyrin||Not Applicable|
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).
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.
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 (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Patients who underwent photodynamic therapy for malignant biliary obstruction.
Procedure: Photodynamic therapy using polyhematoporphyrin
- Safety of photodynamic therapy [ Time Frame: 30 days ]Treatment emergent adverse events
- 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
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
|Principal Investigator:||Werner Dolak, M.D.||Medical University of Vienna|