NCT01859169

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: li xiong · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Photodynamic 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).

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-06-01
• Completion: 2016-06-01
• First posted: 2013-05-21
• Last updated: 2013-05-21

Locations

1 site across 1 country: China