Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

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

Official Title
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A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma

Conditions
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Cholangiocarcinoma

Intervention / Treatment
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* Procedure: Self expanding metallic stent (SEMS)
* Procedure: Endoscopic radiofrequency ablation (ERFA)
* Procedure: Photodynamic therapy (PDT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self expanding metallic stent （SEMS ）placement only<br>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 | Procedure: Self expanding metallic stent (SEMS)<br>* Self expanding metallic stent<br>|
| Experimental: Endoscopic radiofrequency ablation plus SEMS<br>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 | Procedure: Self expanding metallic stent (SEMS)<br>* Self expanding metallic stent<br>Procedure: Endoscopic radiofrequency ablation (ERFA)<br>* Endoscopic radiofrequency ablation<br>|
| Experimental: Photodynamic therapy plus SEMS<br>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 | Procedure: Self expanding metallic stent (SEMS)<br>* Self expanding metallic stent<br>Procedure: Photodynamic therapy (PDT)<br>* Photodynamic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent patency |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival rate |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholangiocarcinoma, Pathologic, Digestive System, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases, Pathological Conditions, Constriction, Adenocarcinoma, Carcinoma