Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction

Klatskin's Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504957
• Other study ID #: EK 1448/2012
• Status: Completed
• Phase: N/A
• First received: July 19, 2015
• Last updated: October 23, 2015
• Start date: July 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Klatskin's Tumor

Intervention

Procedure:
• Photodynamic therapy using polyhematoporphyrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

References & Publications (6)

Berr F, Wiedmann M, Tannapfel A, Halm U, Kohlhaw KR, Schmidt F, Wittekind C, Hauss J, Mössner J. Photodynamic therapy for advanced bile duct cancer: evidence for improved palliation and extended survival. Hepatology. 2000 Feb;31(2):291-8. — View Citation

de Groen PC, Gores GJ, LaRusso NF, Gunderson LL, Nagorney DM. Biliary tract cancers. N Engl J Med. 1999 Oct 28;341(18):1368-78. Review. — View Citation

Gao F, Bai Y, Ma SR, Liu F, Li ZS. Systematic review: photodynamic therapy for unresectable cholangiocarcinoma. J Hepatobiliary Pancreat Sci. 2010 Mar;17(2):125-31. doi: 10.1007/s00534-009-0109-3. Epub 2009 May 20. Review. — View Citation

Ortner MA, Liebetruth J, Schreiber S, Hanft M, Wruck U, Fusco V, Müller JM, Hörtnagl H, Lochs H. Photodynamic therapy of nonresectable cholangiocarcinoma. Gastroenterology. 1998 Mar;114(3):536-42. — View Citation

Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mössner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. — View Citation

Zoepf T, Jakobs R, Arnold JC, Apel D, Riemann JF. Palliation of nonresectable bile duct cancer: improved survival after photodynamic therapy. Am J Gastroenterol. 2005 Nov;100(11):2426-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of photodynamic therapy	Treatment emergent adverse events	30 days	Yes
Secondary	Efficacy of photodynamic therapy	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	No