Clinical Effect and Safety of PDT and RFA for Unresectable EHCC

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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

50

Start Date

March 1, 2020

Completion Date

June 1, 2020

Primary Completion Date

June 1, 2020

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, +8613454132186, [email protected]

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

March 2020