CholangiocarcinomaNCT01859169
Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma
An observational study of Cholangiocarcinoma, run by li xiong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bile duct cancer
Who may be able to join
- 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.
Who cannot join
- 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410016
About this study
Official title: Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma
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
- Being tested
- Photodynamic therapy
- Keywords
- bili duct neoplasms, bile duct cancer, photodynamic therapy, biliary drainage
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Group that be administrated biliary drainage only | |
| PDT Group | Group that be administrated photodynamic therapy and biliary drainage Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: one month
Secondary outcomes (1)
Quality of life
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Modifying the clinnicaltrials
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- li xiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, li xiong, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859169
- Sponsor's protocol ID
- PDT-B-01
- Other IDs
- PDT-B-01
- Status last verified
- May 2013
- First submitted
- 10 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18255347
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT01859169
- Acronym / sponsor ID
- PDT-B-01
- Conditions
- Cholangiocarcinoma
- Keywords
- bili duct neoplasms, bile duct cancer, photodynamic therapy, biliary drainage
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Modifying the clinnicaltrials
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- li xiongUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Group that be administrated biliary drainage only |
| PDT Group | – | Procedure: Photodynamic therapyGroup that be administrated photodynamic therapy and biliary drainage |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bile duct cancer
Key inclusion criteria (1 listed)
- 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.
Key exclusion criteria (1 listed)
- 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodynamic therapyEach 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). | Procedure or surgery | PDT Group |
Primary outcome
Survival rate
Time frame: one month
1 secondary outcome
Quality of life
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Background: PubMed 18255347Kahaleh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiocarcinoma, run by li xiong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.