CholangiocarcinomaNCT02585856
Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
A study testing PDT and stent in people with Cholangiocarcinoma, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- PDT and stent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Aug 2018
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtention of a written informed consent.
- Patient over 18.
- Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
- Patient with Karnofsky score ≥ 50 %
- Patient capable of fill in the quality of life questionnaire
Who cannot join
- No written informed consent.
- Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- Patients with porphyria or hypersensibility to porphyrins.
- Pregnant, parturient or breastfeeding women.
- Patient under 18.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.
Read the detailed description
Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. It is often clinically silent with symptoms developing only in advanced disease. Surgical resection is the recommended curative intervention with only a minority of patients (10-20%) having potentially resectable tumors at time of diagnosis.
Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival.
Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. Several studies suggest PDT plus biliary stent placement may prolong survival (range of 360-630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. The aim of this study is to determine the effectiveness and safety of PDT with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable CCA in China.
- Conditions
- Cholangiocarcinoma
- Being tested
- PDT, stent
- Keywords
- Biliary duct carcinoma, Photodynamic therapy
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDTDevice
Patients with unresectable CCA are performed PDT with ERCP after porfimer sodium （chongqing ray high medical instrument co., LTD，Chongqing, China) i.v. at a dose of 2 mg/kg at 48 h.
PDT procedure: for light distribution, flexible cylindrical diffuser probes mounted on 400-mm quartz fibres with an active distal tip length of 2 cm （chongqing ray high medical instrument co., LTD，Chongqing, China) is used. The light source was a diode laser system with a maximum power output of 2 Wand a wavelength of 633.3 nm. The power emitted by the diffuser tip was calibrated to 400 mW/cm before PDT was administered using an integrating sphere power meter. The mean irradiation time was 452 s (range: 400-600 s), using a power density of 300-400 mW/cm and an energy dose of 180-200 J/cm (of diffuser length).
stentDevice
Patients with unresectable CCA are performed with ERCP, one or several plastic biliary stents (Boston Scientific Corporation, MA,USA) are inserted to ensure adequate decompression and bile drainage.
| Study group | Role | What they receive |
|---|---|---|
| PDT+stent | Experimental | Patients with unresectable CCA are performed PDT and biliary stent with ERCP Receives: Device: PDT; Device: stent |
| stent | Placebo comparator | Patients with unresectable CCA are performed biliary stent with ERCP alone Receives: Device: stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival time
Measured: two years
Secondary outcomes (3)
clinical success rates
The proportion of patients whose bilirubin decreased obviously after procedure
Measured: two years
Karnosky performance status score
Measured: two years
complications
Number of patients with complications,type, frequency and intensity of complications between this two group will be compared
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startFeb 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, M.S, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585856
- Sponsor's protocol ID
- 2012-001-02
- Status last verified
- Dec 2018
- First submitted
- 1 Oct 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: publication
Publications
Rustagi T, Jamidar PA. Endoscopic treatment of malignant biliary strictures. Curr Gastroenterol Rep. 2015 Jan;17(1):426. doi: 10.1007/s11894-014-0426-9.
PubMed 25613178Wagner A, Kiesslich T, Neureiter D, Friesenbichler P, Puespoek A, Denzer UW, Wolkersdorfer GW, Emmanuel K, Lohse AW, Berr F. Photodynamic therapy for hilar bile duct cancer: clinical evidence for improved tumoricidal tissue penetration by temoporfin. Photochem Photobiol Sci. 2013 Jun;12(6):1065-73. doi: 10.1039/c3pp25425a. Epub 2013 Apr 4.
PubMed 23558738Lee TY, Cheon YK, Shim CS, Cho YD. Photodynamic therapy prolongs metal stent patency in patients with unresectable hilar cholangiocarcinoma. World J Gastroenterol. 2012 Oct 21;18(39):5589-94. doi: 10.3748/wjg.v18.i39.5589.
PubMed 23112552Kahaleh M. Photodynamic therapy in cholangiocarcinoma. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S44-7. doi: 10.6004/jnccn.2012.0174.
PubMed 23055215Leggett CL, Gorospe EC, Murad MH, Montori VM, Baron TH, Wang KK. Photodynamic therapy for unresectable cholangiocarcinoma: a comparative effectiveness systematic review and meta-analyses. Photodiagnosis Photodyn Ther. 2012 Sep;9(3):189-95. doi: 10.1016/j.pdpdt.2012.03.002. Epub 2012 Apr 11.
PubMed 22959798
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02585856
- Acronym / sponsor ID
- 2012-001-02
- Conditions
- Cholangiocarcinoma
- Keywords
- Biliary duct carcinoma, Photodynamic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Oct 2015 (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.
The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.
Detailed description
Cholangiocarcinoma (CCA) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. It is often clinically silent with symptoms developing only in advanced disease. Surgical resection is the recommended curative intervention with only a minority of patients (10-20%) having potentially resectable tumors at time of diagnosis.
Endoscopic palliative therapy in CCA entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. Although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival.
Photodynamic therapy (PDT) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. Several studies suggest PDT plus biliary stent placement may prolong survival (range of 360-630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. The aim of this study is to determine the effectiveness and safety of PDT with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable CCA in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDT+stent | Experimental | Device: PDT, Device: stentPatients with unresectable CCA are performed PDT and biliary stent with ERCP |
| stent | Placebo comparator | Device: stentPatients with unresectable CCA are performed biliary stent with ERCP alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obtention of a written informed consent.
- Patient over 18.
- Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA.
- Patient with Karnofsky score ≥ 50 %
- Patient capable of fill in the quality of life questionnaire
Key exclusion criteria (5 listed)
- No written informed consent.
- Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma.
- Patients with porphyria or hypersensibility to porphyrins.
- Pregnant, parturient or breastfeeding women.
- Patient under 18.
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 |
|---|---|---|
| PDTPatients with unresectable CCA are performed PDT with ERCP after porfimer sodium （chongqing ray high medical instrument co., LTD，Chongqing, China) i.v. at a dose of 2 mg/kg at 48 h. PDT procedure: for light distribution, flexible cylindrical diffuser probes mounted on 400-mm quartz fibres with an active distal tip length of 2 cm （chongqing ray high medical instrument co., LTD，Chongqing, China) is used. The light source was a diode laser system with a maximum power output of 2 Wand a wavelength of 633.3 nm. The power emitted by the diffuser tip was calibrated to 400 mW/cm before PDT was administered using an integrating sphere power meter. The mean irradiation time was 452 s (range: 400-600 s), using a power density of 300-400 mW/cm and an energy dose of 180-200 J/cm (of diffuser length). | Device | PDT+stent |
| stentPatients with unresectable CCA are performed with ERCP, one or several plastic biliary stents (Boston Scientific Corporation, MA,USA) are inserted to ensure adequate decompression and bile drainage. | Device | PDT+stent, stent |
Primary outcome
survival time
Time frame: two years
3 secondary outcomes
clinical success rates
Time frame: two years
Karnosky performance status score
Time frame: two years
complications
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Background: PubMed 25613178Rustagi T, Jamidar PA. Endoscopic treatment of malignant biliary strictures. Curr Gastroenterol Rep. 2015 Jan;17(1):426. doi: 10.1007/s11894-014-0426-9.
- Results publication: PubMed 23558738Wagner A, Kiesslich T, Neureiter D, Friesenbichler P, Puespoek A, Denzer UW, Wolkersdorfer GW, Emmanuel K, Lohse AW, Berr F. Photodynamic therapy for hilar bile duct cancer: clinical evidence for improved tumoricidal tissue penetration by temoporfin. Photochem Photobiol Sci. 2013 Jun;12(6):1065-73. doi: 10.1039/c3pp25425a. Epub 2013 Apr 4.
- Results publication: PubMed 23112552Lee TY, Cheon YK, Shim CS, Cho YD. Photodynamic therapy prolongs metal stent patency in patients with unresectable hilar cholangiocarcinoma. World J Gastroenterol. 2012 Oct 21;18(39):5589-94. doi: 10.3748/wjg.v18.i39.5589.
- Results publication: PubMed 23055215Kahaleh M. Photodynamic therapy in cholangiocarcinoma. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S44-7. doi: 10.6004/jnccn.2012.0174.
- Results publication: PubMed 22959798Leggett CL, Gorospe EC, Murad MH, Montori VM, Baron TH, Wang KK. Photodynamic therapy for unresectable cholangiocarcinoma: a comparative effectiveness systematic review and meta-analyses. Photodiagnosis Photodyn Ther. 2012 Sep;9(3):189-95. doi: 10.1016/j.pdpdt.2012.03.002. Epub 2012 Apr 11.
- Individual participant dataSharing planned: Yes. publication
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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.
Xiaofeng Zhang, M.S principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDT and stent in people with Cholangiocarcinoma, run by First People's Hospital of Hangzhou 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 time (time frame: two years). 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 NCT02585856, which also lists 5 linked publications.
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 19 Dec 2018.