No registrations found.
ID
Source
Brief title
Health condition
non-resectable bile duct tumor
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival.
Secondary outcome
1. 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.
Background summary
N/A
Study objective
Due 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.
Intervention
Endoscopic 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.
P.O. Box 22660
E.A.J. Rauws
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
e.a.rauws@amc.uva.nl
P.O. Box 22660
E.A.J. Rauws
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
e.a.rauws@amc.uva.nl
Inclusion criteria
1. Proven irresectable bile duct tumor;
2. Adequate drainage bile ducts with plastic endoprothese(s);
3. Karnofsky index > 30%;
4. Age > 18 year.
Exclusion criteria
1. Porfyria;
2. Previous chemo-/or radiotherapy;
3. Presence of metalic endoprothese(s);
4. Active cholangitis;
5. Primary sclerosing cholangitis;
6. Karnofsky index < 30%.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL128 |
| NTR-old | NTR162 |
| Other | : 04/161 |
| ISRCTN | ISRCTN43588830 |