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

RECRUITINGN/ASponsored by First People's Hospital of Hangzhou
Actively Recruiting
PhaseN/A
SponsorFirst People's Hospital of Hangzhou
Started2023-01-01
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions3

Bile Duct CancerCancerExtrahepatic Cholangiocarcinoma

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