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Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01859169
Enrollment
100
Registered
2013-05-21
Start date
2013-06-30
Completion date
2016-06-30
Last updated
2013-05-21

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

Conditions

Cholangiocarcinoma

Keywords

bili duct neoplasms, bile duct cancer, photodynamic therapy, biliary drainage

Brief summary

This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.

Interventions

PROCEDUREPhotodynamic therapy

Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).

Sponsors

li xiong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.

Exclusion criteria

* 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer

Design outcomes

Primary

MeasureTime frame
Survival rateone month

Secondary

MeasureTime frame
Quality of lifeone month

Other

MeasureTime frame
Complication of therapyone month

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026