Clinical Effect and Safety of PDT and RFA for Unresectable EHCC

Zhejiang University

Status

Completed

Conditions

Cholangiocarcinoma

Treatments

Procedure: Photodynamic therapy

Procedure: radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT04301999

2016RCB015

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.