Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01859169
• Other study ID #: PDT-B-01
• Secondary ID: PDT-B-01
• Status: Suspended
• Phase: Phase 2/Phase 3
• First received: May 10, 2013
• Last updated: May 17, 2013
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2013
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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).

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
li xiong

Country where clinical trial is conducted

China, 

References & Publications (1)

Kahaleh M, Mishra R, Shami VM, Northup PG, Berg CL, Bashlor P, Jones P, Ellen K, Weiss GR, Brenin CM, Kurth BE, Rich TA, Adams RB, Yeaton P. Unresectable cholangiocarcinoma: comparison of survival in biliary stenting alone versus stenting with photodynamic therapy. Clin Gastroenterol Hepatol. 2008 Mar;6(3):290-7. doi: 10.1016/j.cgh.2007.12.004. Epub 2008 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication of therapy		one month	No
Primary	Survival rate		one month	No
Secondary	Quality of life		one month	No

External Links

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