Overview

This trial is active, not recruiting.

Condition cholangiocarcinoma
Treatments pdt, stent
Sponsor First People's Hospital of Hangzhou
Start date February 2013
End date December 2015
Trial size 39 participants
Trial identifier NCT02585856, 2012-001-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Placebo Comparator)
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.

Primary Outcomes

Measure
survival time
time frame: two years

Secondary Outcomes

Measure
complications
time frame: two years
clinical success rates
time frame: two years
Karnosky performance status score
time frame: two years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
Principal investigator Xiaofeng Zhang, M.S
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by First People's Hospital of Hangzhou.