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Photodynamic therapy for the palliation of non-resectable proximal cholangiocarcinoma.


- candidate number1274
- NTR NumberNTR162
- ISRCTNISRCTN43588830
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR30-aug-2005
- Secondary IDs04/161 
- Public TitlePhotodynamic therapy for the palliation of non-resectable proximal cholangiocarcinoma.
- Scientific TitlePhotodynamic therapy for the palliation of non-resectable proximal cholangiocarcinoma.
- ACRONYMPDT
- hypothesisDue to tumoricidal effect of PDT , it is expected that the central bile ducts remain free from tumor and so better and prolonged drainage can be achieved leading to beter QoL and survival.
- Healt Condition(s) or Problem(s) studiedCancer, Bile duct tumor, Cholangiocarcinoma
- Inclusion criteria1. Proven irresectable bile duct tumor;
2. Adequate drainage bile ducts with plastic endoprothese(s);
3. Karnofsky index > 30%;
4. Age > 18 year.
- Exclusion criteria1. Porfyria;
2. Previous chemo-/or radiotherapy;
3. Presence of metalic endoprothese(s);
4. Active cholangitis;
5. Primary sclerosing cholangitis;
6. Karnofsky index < 30%.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2005
- planned closingdate1-jan-2008
- Target number of participants75
- InterventionsEndoscopic treatment with plastic endoprotheses (=current standard).
Versus
Endoscopiccteratment with plastic endoprotheses with, during this procedure, internal illumination of the tumor with light of a specific wavelenght after infusion of a photosensitizer.
- Primary outcomeSurvival.
- Secondary outcome1. Number of repeat invasive procedures;
2. Lenght hospitalization;
3. Level of cholestasis;
4. Rates of cholangiographic tumor response;
5. Karnofsky performance;
6. Quality of life;
7. Adverse events.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. E.A.J. Rauws
- CONTACT for SCIENTIFIC QUERIESDr. E.A.J. Rauws
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
[default]
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD23-aug-2005 - 15-dec-2006


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