NCT02504957

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

July 19, 2015

Last Update Submit

October 23, 2015

Conditions

Klatskin's Tumor

Keywords

Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

  • Safety of photodynamic therapy

    Treatment emergent adverse events

    30 days

Secondary Outcomes (1)

  • Efficacy of photodynamic therapy

    From date of first photodynamic therapy until date of death from any cause, assessed up to 100 months

Study Arms (1)

Photodynamic therapy

OTHER

Patients who underwent photodynamic therapy for malignant biliary obstruction.

Procedure: Photodynamic therapy using polyhematoporphyrin

Interventions

Photodynamic therapy using polyhematoporphyrinPROCEDURE
Photodynamic therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 10536130BACKGROUND

  • 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: 9496944BACKGROUND

  • 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: 10655248BACKGROUND

  • 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: 19455276BACKGROUND

  • 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: 16279895BACKGROUND

  • 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: 14598251BACKGROUND

  • 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.

    PMID: 28405328DERIVED

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Werner Dolak, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant doctor

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 22, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 26, 2015

Record last verified: 2015-10