Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Phase 2

• Conditions: Cholangiocarcinoma

• Registration Number: NCT01739465
• Lead Sponsor: Guangzhou Medical University

Brief Summary

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-25
• Last Update Posted: 2013-02-26
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≥ 18 years old
• Pathologically or radiologically confirmed biliary malignant
• Inoperability by staging

Exclusion Criteria

• Cholangiocarcinoma with widespread metastasis
• Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
• Prior SEMS placement
• Pregnancy
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
• Life expectancy < 3months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
stent patency	6 months

Secondary Outcome Measures

Name	Time	Method
overall survival rate	3 years

Trial Locations

Locations (2)

The Second Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China

The second hospital of Guangzhou Medical college; 🇨🇳 Guangzhou, Guangdong, China