Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02504957
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2015-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018285', 'term': 'Klatskin Tumor'}], 'ancestors': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2015-07-19', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of photodynamic therapy', 'timeFrame': '30 days', 'description': 'Treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Efficacy of photodynamic therapy', 'timeFrame': 'From date of first photodynamic therapy until date of death from any cause, assessed up to 100 months', 'description': 'Overall survival as surrogate marker of treatment efficacy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Photodynamic therapy'], 'conditions': ["Klatskin's Tumor"]}, 'referencesModule': {'references': [{'pmid': '10536130', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJM199910283411807. No abstract available.'}, {'pmid': '9496944', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10655248', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19455276', 'type': 'BACKGROUND', '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.'}, {'pmid': '16279895', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1572-0241.2005.00318.x.'}, {'pmid': '14598251', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28405328', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'INTRODUCTION\n\nMalignant 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).\n\nSTUDY AIMS\n\nThe 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.\n\nMETHODS\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone photodynamic therapy as a treatment for malignant biliary obstruction.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02504957', 'briefTitle': 'Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Photodynamic Therapy With Polyhematoporphyrin for Malignant Biliary Obstruction - a Retrospective Analysis.', 'orgStudyIdInfo': {'id': 'EK 1448/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Photodynamic therapy', 'description': 'Patients who underwent photodynamic therapy for malignant biliary obstruction.', 'interventionNames': ['Procedure: Photodynamic therapy using polyhematoporphyrin']}], 'interventions': [{'name': 'Photodynamic therapy using polyhematoporphyrin', 'type': 'PROCEDURE', 'armGroupLabels': ['Photodynamic therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Werner Dolak, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant doctor', 'investigatorFullName': 'Werner Dolak, MD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}