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Trial Title:
Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma
NCT ID:
NCT05519319
Condition:
Extrahepatic Cholangiocarcinoma
Bile Duct Cancer
Conditions: Official terms:
Cholangiocarcinoma
Bile Duct Neoplasms
Conditions: Keywords:
Extrahepatic cholangiocarcinoma
Photodynamic therapy
Radiofrequency ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Three parallel groups
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Outcome Assessor are unaware about the results
Intervention:
Intervention type:
Procedure
Intervention name:
RFA
Description:
RFA will be performed
Arm group label:
Radiofrequency ablation(RFA)
Other name:
ERCP guided
Intervention type:
Procedure
Intervention name:
PDT
Description:
PDT will be performed
Arm group label:
Photodynamic therapy(PDT)
Other name:
ERCP guided
Intervention type:
Procedure
Intervention name:
RFA combined with PDT
Description:
RFA and PDT will be performed
Arm group label:
RFA+PDT
Other name:
ERCP guided
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.
Criteria for 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
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou First People's Hospital
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianfeng Yang
Phone:
13454132186
Start date:
January 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
First People's Hospital of Hangzhou
Agency class:
Other
Source:
First People's Hospital of Hangzhou
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05519319
