Photodynamic therapy for the palliation of non-resectable proximal cholangiocarcinoma
| ISRCTN | ISRCTN43588830 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43588830 |
| Secondary identifying numbers | 04/161; NTR162 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Dr E.A.J. Rauws
Scientific
Scientific
Academic Medical Centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| e.a.rauws@amc.uva.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2005 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
