Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Guangzhou Medical University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cholangiocarcinoma

Treatments: Procedure: Endoscopic radiofrequency ablation (ERFA); Procedure: Photodynamic therapy (PDT); Procedure: Self expanding metallic stent (SEMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01739465

RFA2012

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Self expanding metallic stent （SEMS ）placement only

Active Comparator group

Description:

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

Treatment:

Procedure: Self expanding metallic stent (SEMS)

Endoscopic radiofrequency ablation plus SEMS

Experimental group

Description:

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

Treatment:

Procedure: Self expanding metallic stent (SEMS)

Procedure: Endoscopic radiofrequency ablation (ERFA)

Photodynamic therapy plus SEMS

Experimental group

Description:

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

Treatment:

Procedure: Self expanding metallic stent (SEMS)

Procedure: Photodynamic therapy (PDT)