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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20863

Enrollment

Registered

2005-08-30

Start date

2005-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-resectable bile duct tumor

Interventions

Endoscopic treatment with plastic endoprotheses (=current standard). Versus Endoscopiccteratment with plastic endoprotheses with, during this procedure, internal illumination of the tumor with light

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Survival.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactE.A.J. Rauws

Academic Medical Center (AMC), C2-327, P.O. Box 22660

e.a.rauws@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)