Extrahepatic Cholangiocarcinoma, Bile Duct Cancer
Conditions
Keywords
Extrahepatic cholangiocarcinoma, Photodynamic therapy, Radiofrequency ablation
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.
Interventions
PROCEDURERFA
RFA will be performed
PROCEDUREPDT
PDT will be performed
PROCEDURERFA combined with PDT
RFA and PDT will be performed
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome Assessor are unaware about the results
Intervention model description
Three parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Three years | OS was defined as the time from initial RFA or PDT to death or the end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Three years | Number of patients with adverse events |
| Progression-free survival(PFS) | Three years | PFS was measured from therapy until the date of disease progression or death |
Countries
China
Contacts
Primary ContactJianfeng Yang, Doctor
Backup ContactHayat Khizar, MD
Outcome results
None listed