Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E.A.J. Rauws

ORCID ID

Contact details

Academic Medical Centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 9111
e.a.rauws@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

04/161; NTR162

Study information

Scientific title

Acronym

PDT

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Survival

Secondary outcome measures

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

Overall trial start date

01/01/2005

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant 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%

Recruitment start date

01/01/2005

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes