RecruitingNot ApplicableNCT05519319

Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma

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

Sponsor

First People's Hospital of Hangzhou

Enrollment

70 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Bile Duct Cancer Extrahepatic Cholangiocarcinoma

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

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 Criteria6

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.