Clinical Effect and Safety of PDT and RFA for Unresectable EHCC
- Conditions
- Cholangiocarcinoma
- Interventions
- Procedure: Photodynamic therapyProcedure: radiofrequency ablation
- Registration Number
- NCT04301999
- Lead Sponsor
- First People's Hospital of Hangzhou
- Brief Summary
The prognosis of patients with advanced unresectable EHCC is very poor with a median survival of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is by far the only modality that has shown to improve stent patency as well as over survival (OS) in patients with cholangiocarcinoma. In recent years, many studies have shown that endoscopic radiofrequency ablation (RFA) extends stent patency and possibly the survival of patients with malignant biliary obstruction. However, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.
- Detailed Description
Extrahepatic cholangiocarcinoma (EHCC) originates from the hepatic hilar region to the lower common bile duct. The prognosis of patients with advanced unresectable EHCC is very poor with a median survival of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is by far the only modality that has shown to improve stent patency as well as over survival (OS) in patients with cholangiocarcinoma. In an attempt to improve stent patency placed for malignant biliary obstruction, enthusiasm for endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has been increasing in recent years. The HABIBTM EndoHBP catheter is an endoscopic bipolar RFA catheter with proven safety and effectiveness for biliary RFA of cholangiocarcinoma. Many studies have shown that endoscopic RFA extends stent patency and possibly the survival of patients with malignant biliary obstruction. However, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDT group Photodynamic therapy Patients in PDT group underwnt PDT RFA group radiofrequency ablation Patients in RFA group underwent RFA
- Primary Outcome Measures
Name Time Method Overall survival (OS) two years OS was defined as the time from initial RFA to death or the end of the study.
- Secondary Outcome Measures
Name Time Method Adverse events two years Number of patients with adverse events
Progression-free survival (PFS) two years PFS was measured from randomization until the date of disease progression or death
Trial Locations
- Locations (1)
Jianfeng Yang
🇨🇳Hangzhou, Zhejiang, China