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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic therapy | Other | Patients who underwent photodynamic therapy for malignant biliary obstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic therapy using polyhematoporphyrin | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of photodynamic therapy | Treatment emergent adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Werner Dolak, M.D. | Medical University of Vienna | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10536130 | Background | 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. doi: 10.1056/NEJM199910283411807. No abstract available. | |
| 9496944 | Background | Ortner MA, Liebetruth J, Schreiber S, Hanft M, Wruck U, Fusco V, Muller JM, Hortnagl H, Lochs H. Photodynamic therapy of nonresectable cholangiocarcinoma. Gastroenterology. 1998 Mar;114(3):536-42. doi: 10.1016/s0016-5085(98)70537-2. |
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| ID | Term |
|---|---|
| D018285 | Klatskin Tumor |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| 10655248 | Background | Berr F, Wiedmann M, Tannapfel A, Halm U, Kohlhaw KR, Schmidt F, Wittekind C, Hauss J, Mossner J. Photodynamic therapy for advanced bile duct cancer: evidence for improved palliation and extended survival. Hepatology. 2000 Feb;31(2):291-8. doi: 10.1002/hep.510310205. |
| 19455276 | Background | 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. |
| 16279895 | Background | 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. doi: 10.1111/j.1572-0241.2005.00318.x. |
| 14598251 | Background | Ortner ME, Caca K, Berr F, Liebetruth J, Mansmann U, Huster D, Voderholzer W, Schachschal G, Mossner J, Lochs H. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003 Nov;125(5):1355-63. doi: 10.1016/j.gastro.2003.07.015. |
| 28405328 | Derived | Dolak W, Schwaighofer H, Hellmich B, Stadler B, Spaun G, Plieschnegger W, Hebenstreit A, Weber-Eibel J, Siebert F, Emmanuel K, Knoflach P, Gschwantler M, Vogel W, Trauner M, Puspok A; Austrian PDT study group. Photodynamic therapy with polyhematoporphyrin for malignant biliary obstruction: A nationwide retrospective study of 150 consecutive applications. United European Gastroenterol J. 2017 Feb;5(1):104-110. doi: 10.1177/2050640616654037. Epub 2016 Jul 7. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |