Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2018

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.

Interventions

  • Device: 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).
  • Device: 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.

Arms, Groups and Cohorts

  • Experimental: PDT+stent
    • Patients with unresectable CCA are performed PDT and biliary stent with ERCP
  • Placebo Comparator: stent
    • Patients with unresectable CCA are performed biliary stent with ERCP alone

Clinical Trial Outcome Measures

Primary Measures

  • survival time
    • Time Frame: two years

Secondary Measures

  • clinical success rates
    • Time Frame: two years
    • The proportion of patients whose bilirubin decreased obviously after procedure
  • Karnosky performance status score
    • Time Frame: two years
  • complications
    • Time Frame: two years
    • Number of patients with complications,type, frequency and intensity of complications between this two group will be compared

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First People’s Hospital of Hangzhou
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jianfeng Yang, associate director – First People’s Hospital of Hangzhou
  • Overall Official(s)
    • Xiaofeng Zhang, M.S, Principal Investigator, First People’s Hospital of Hangzhou

References

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.

Citations Reporting on Results

Wagner A, Kiesslich T, Neureiter D, Friesenbichler P, Puespoek A, Denzer UW, Wolkersdörfer 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.

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. Review.

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