Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585856
• Other study ID #: 2012-001-02
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: August 2018

Study information

• Verified date: December 2018
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 PDT by observing the complications after the procedure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

References & Publications (5)

Kahaleh M. Photodynamic therapy in cholangiocarcinoma. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S44-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Phot — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival time		two years
Secondary	clinical success rates	The proportion of patients whose bilirubin decreased obviously after procedure	two years
Secondary	Karnosky performance status score		two years
Secondary	complications	Number of patients with complications,type, frequency and intensity of complications between this two group will be compared	two years