Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

Not Applicable

Completed

• Conditions: Cholangiocarcinoma
• Interventions: Device: PDT; Device: stent

• Registration Number: NCT02585856
• Lead Sponsor: First People's Hospital of Hangzhou

Brief 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.

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDT+stent	PDT	Patients with unresectable CCA are performed PDT and biliary stent with ERCP
PDT+stent	stent	Patients with unresectable CCA are performed PDT and biliary stent with ERCP
stent	stent	Patients with unresectable CCA are performed biliary stent with ERCP alone

Primary Outcome Measures

Name	Time	Method
survival time	two years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China