Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma

Study Overview
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Brief Summary
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A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.

Detailed Description
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The lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (EHCC). Patients with advanced, unresectable EHCC have a relatively poor prognosis, with a median survival time of 3 to 6 months. The only way to prolong stent patency and survival for patients with unresectable locally advanced EHCC is by active control of tumor development. The only treatment that has consistently demonstrated an improvement in stent patency and overall survival (OS) in cholangiocarcinoma patients is photodynamic therapy (PDT). The popularity of endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.RFA for biliary cholangiocarcinoma has demonstrated safety and effectiveness. Endoscopic RFA has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. The clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.

Official Title
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Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma

Conditions
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Extrahepatic Cholangiocarcinoma, Bile Duct Cancer

Intervention / Treatment
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* Procedure: RFA
* Procedure: PDT
* Procedure: RFA combined with PDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed cholangiocarcinoma; unresectable cholangiocarcinoma due to local infiltration of major vessels according to computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound（EUS）; No previous treatment; Adequate bone marrow and organ function (white blood cells>4.0×109/L, hemoglobin>90 g/L, and platelets>75×109/L, serum creatinine<2.0 mg/dl); A Karnofsky performance status (KPS) score ≥ 50; Signed written informed consent. Exclusion Criteria: Imaging examination (CT, MRCP, EUS) showed distant metastasis of liver, lung and other organs; Coexistent with other malignant tumors; Pregnant or nursing women; Previous gastrointestinal diversion; Participation in another study during the month before enrollment in this study; Alcohol and/or substance abuse or potentially poor compliance per a doctor's judgment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three parallel groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Photodynamic therapy(PDT)<br>The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. | Procedure: PDT<br>* PDT will be performed<br>* Other names: ERCP guided;|
| Active Comparator: Radiofrequency ablation(RFA)<br>An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. | Procedure: RFA<br>* RFA will be performed<br>* Other names: ERCP guided;|
| Active Comparator: RFA+PDT<br>The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s. After that An RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds. | Procedure: RFA combined with PDT<br>* RFA and PDT will be performed<br>* Other names: ERCP guided;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | OS was defined as the time from initial RFA or PDT to death or the end of the study. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of patients with adverse events | Three years | 
| Progression-free survival(PFS) | PFS was measured from therapy until the date of disease progression or death | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation