Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
NCT ID: NCT02585856
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2013-02-28
2018-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PDT+stent
Patients with unresectable CCA are performed PDT and biliary stent with ERCP
PDT
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).
stent
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.
stent
Patients with unresectable CCA are performed biliary stent with ERCP alone
stent
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.
Interventions
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PDT
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).
stent
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Responsible Party
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Jianfeng Yang
associate director
Principal Investigators
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Xiaofeng Zhang, M.S
Role: PRINCIPAL_INVESTIGATOR
First People's Hospital of Hangzhou
Locations
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Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Countries
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References
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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.
Wagner 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.
Lee 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.
Kahaleh M. Photodynamic therapy in cholangiocarcinoma. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S44-7. doi: 10.6004/jnccn.2012.0174.
Leggett 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.
Other Identifiers
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2012-001-02
Identifier Type: -
Identifier Source: org_study_id