Back to resultsSafety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
Primary Purpose
Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
RFA
PDT
RFA combined with PDT
Sponsored by
About this trial
This is an interventional treatment trial for Extrahepatic Cholangiocarcinoma focused on measuring Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
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.
Sites / Locations
- Hangzhou First People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Photodynamic therapy(PDT)
Radiofrequency ablation(RFA)
RFA+PDT
Arm Description
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the PDT optical fiber directly across the stricture.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.
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.
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the 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. After that 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.
Outcomes
Primary Outcome Measures
Overall survival (OS)
OS was defined as the time from initial RFA or PDT to death or the end of the study.
Secondary Outcome Measures
Adverse events
Number of patients with adverse events
Progression-free survival(PFS)
PFS was measured from therapy until the date of disease progression or death
Full Information
NCT ID
NCT05519319
First Posted
August 24, 2022
Last Updated
February 18, 2023
Sponsor
First People's Hospital of Hangzhou
1. Study Identification
Unique Protocol Identification Number
NCT05519319
Brief Title
Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
Official Title
Clinical Effect and Safety of Photodynamic Therapy Versus Radiofrequency Ablation Versus Photodynamic Therapy Plus Radiofrequency Ablation for Unresectable Extrahepatic Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.
Detailed Description
The lower common bile duct and the hepatic hilar area are the origin of extrahepatic cholangiocarcinoma (EHCC). Patients with advanced, unresectable EHCC have a relatively poor prognosis, with a median survival time of 3 to 6 months. The only way to prolong stent patency and survival for patients with unresectable locally advanced EHCC is by active control of tumor development. The only treatment that has consistently demonstrated an improvement in stent patency and overall survival (OS) in cholangiocarcinoma patients is photodynamic therapy (PDT). The popularity of endoscopic retrograde cholangio-pancreatography (ERCP)-guided radiofrequency ablation (RFA) has grown recently in an effort to increase stent patency and survival time for patients with malignant biliary obstruction.RFA for biliary cholangiocarcinoma has demonstrated safety and effectiveness. Endoscopic RFA has been shown in various studies to prolong stent patency and the survival of patients with malignant biliary obstruction. The clinical effectiveness and adverse events of these two endoscopic treatments have not been compared in many papers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
Keywords
Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three parallel groups
Masking
Outcomes Assessor
Masking Description
Outcome Assessor are unaware about the results
Allocation
Non-Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photodynamic therapy(PDT)
Arm Type
Active Comparator
Arm Description
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the 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.
Arm Title
Radiofrequency ablation(RFA)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RFA+PDT
Arm Type
Active Comparator
Arm Description
The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visual-radiography. The dilation catheter was then withdrawn to leave the 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. After that 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.
Intervention Type
Procedure
Intervention Name(s)
RFA
Other Intervention Name(s)
ERCP guided
Intervention Description
RFA will be performed
Intervention Type
Procedure
Intervention Name(s)
PDT
Other Intervention Name(s)
ERCP guided
Intervention Description
PDT will be performed
Intervention Type
Procedure
Intervention Name(s)
RFA combined with PDT
Other Intervention Name(s)
ERCP guided
Intervention Description
RFA and PDT will be performed
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
OS was defined as the time from initial RFA or PDT to death or the end of the study.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of patients with adverse events
Time Frame
Three years
Title
Progression-free survival(PFS)
Description
PFS was measured from therapy until the date of disease progression or death
Time Frame
Three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Yang, Doctor
Phone
+8613454132186
Email
yjf-1976@163.com, yjf3303@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hayat Khizar, MD
Phone
+8613757147405
Email
3180018940@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Yang
Phone
13454132186
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yet not decided
Citations:
PubMed Identifier
33359435
Citation
Gao DJ, Yang JF, Ma SR, Wu J, Wang TT, Jin HB, Xia MX, Zhang YC, Shen HZ, Ye X, Zhang XF, Hu B. Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial. Gastrointest Endosc. 2021 Jul;94(1):91-100.e2. doi: 10.1016/j.gie.2020.12.016. Epub 2020 Dec 24.
Results Reference
background
PubMed Identifier
34995788
Citation
Chen P, Yang T, Shi P, Shen J, Feng Q, Su J. Benefits and safety of photodynamic therapy in patients with hilar cholangiocarcinoma: A meta-analysis. Photodiagnosis Photodyn Ther. 2022 Mar;37:102712. doi: 10.1016/j.pdpdt.2022.102712. Epub 2022 Jan 5.
Results Reference
result
PubMed Identifier
33104917
Citation
Li Z, Jiang X, Xiao H, Chen S, Zhu W, Lu H, Cao L, Xue P, Li H, Zhang D. Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma. Surg Endosc. 2021 Oct;35(10):5655-5664. doi: 10.1007/s00464-020-08095-1. Epub 2020 Oct 26.
Results Reference
result
PubMed Identifier
29342492
Citation
Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17.
Results Reference
result
Learn more about this trial
Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
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