Study Stopped
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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
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMay 21, 2013
May 1, 2013
2 years
May 10, 2013
May 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate
one month
Secondary Outcomes (1)
Quality of life
one month
Other Outcomes (1)
Complication of therapy
one month
Study Arms (2)
Control Group
Group that be administrated biliary drainage only
PDT Group
Group that be administrated photodynamic therapy and biliary drainage
Interventions
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).
Eligibility Criteria
Patients with bile duct cancer
You may qualify if:
- Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.
You may not qualify if:
- Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- li xionglead
Study Sites (1)
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410016, China
Related 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.
PMID: 18255347BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor（visiting staff）
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 21, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
May 21, 2013
Record last verified: 2013-05