Clinical Effect and Safety of PDT and RFA for Unresectable EHCC

Clinical Effect and Safety of Photodynamic Therapy With Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma

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.

Study Overview

• Status: Completed
• Conditions: Cholangiocarcinoma
• Intervention / Treatment: Procedure: Photodynamic therapy; Procedure: radiofrequency ablation

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
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Jianfeng Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PDT group; Patients in PDT group underwnt PDT	Procedure: Photodynamic therapy; The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visualradiography. The dilation catheter was then withdrawn to leavethe 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.; Other Names: PDT
EXPERIMENTAL: RFA group; Patients in RFA group underwent RFA	Procedure: radiofrequency ablation; 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.; Other Names: RFA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): August 27, 2021
• Study Completion (ACTUAL): August 27, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (ACTUAL): March 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: radiofrequency ablation; Photodynamic therapy; extrahepatic cholangiocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: 2016RCB015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No