Brief Title
Clinical Effect and Safety of PDT and RFA for Unresectable EHCC
Official Title
Clinical Effect and Safety of Photodynamic Therapy With Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
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.
Study Type
Interventional
Primary Outcome
Overall survival (OS)
Secondary Outcome
Adverse events
Condition
Cholangiocarcinoma
Intervention
Photodynamic therapy
Study Arms / Comparison Groups
PDT group
Description: Patients in PDT group underwnt PDT
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
67
Start Date
March 1, 2020
Completion Date
August 27, 2021
Primary Completion Date
August 27, 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Jianfeng Yang, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04301999
Organization ID
2016RCB015
Responsible Party
Principal Investigator
Study Sponsor
First People's Hospital of Hangzhou
Study Sponsor
Jianfeng Yang, Principal Investigator, First People's Hospital of Hangzhou
Verification Date
August 2021