Photodynamic therapy for the palliation of non-resectable proximal cholangiocarcinoma

ISRCTN	ISRCTN43588830
DOI	https://doi.org/10.1186/ISRCTN43588830
Protocol serial number	04/161; NTR162
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr E.A.J. Rauws
Scientific

Academic Medical Centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 9111
Email	e.a.rauws@amc.uva.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PDT
Study objectives	Due to tumouricidal effect of photodynamic therapy (PDT), it is expected that the central bile ducts remain free from tumour and so better and prolonged drainage can be achieved leading to better quality of life (QoL) and survival.
Ethics approval(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Bile duct tumour, cholangiocarcinoma
Intervention	Endoscopic treatment with plastic endoprotheses (= current standard) versus endoscopic treatment with plastic endoprotheses with, during this procedure, internal illumination of the tumour with light of a specific wavelength after infusion of a photosensitiser.
Intervention type	Other
Primary outcome measure(s)	Survival
Key secondary outcome measure(s)	1. Number of repeat invasive procedures 2. Lenght hospitalisation 3. Level of cholestasis 4. Rates of cholangiographic tumour response 5. Karnofsky performance 6. Quality of life 7. Adverse events
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	75
Key inclusion criteria	1. Proven irresectable bile duct tumour 2. Adequate drainage bile ducts with - plastic endoprothese(s) 3. Karnofsky index greater than 30% 4. Aged greater than 18 years
Key exclusion criteria	1. Porphyria 2. Previous chemo-/or radiotherapy 3. Presence of metallic endoprothese(s) 4. Active cholangitis 5. Primary sclerosing cholangitis 6. Karnofsky index less than 30%
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2008

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan