Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Phase 2

• Conditions: Cholangiocarcinoma
• Interventions: Procedure: Self expanding metallic stent (SEMS); Procedure: Endoscopic radiofrequency ablation (ERFA); Procedure: Photodynamic therapy (PDT)

• 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

Arm && Interventions

Group	Intervention	Description
Self expanding metallic stent （SEMS ）placement only	Self expanding metallic stent (SEMS)	Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
Endoscopic radiofrequency ablation plus SEMS	Self expanding metallic stent (SEMS)	Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
Endoscopic radiofrequency ablation plus SEMS	Endoscopic radiofrequency ablation (ERFA)	Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
Photodynamic therapy plus SEMS	Self expanding metallic stent (SEMS)	Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing
Photodynamic therapy plus SEMS	Photodynamic therapy (PDT)	Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing

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