An interventional study of RFA and PDT in Extrahepatic Cholangiocarcinoma and Bile Duct Cancer, sponsored by First People's Hospital of Hangzhou. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by First People's Hospital of Hangzhou · Not applicable, Interventional, and Treatment
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →First People's Hospital of Hangzhou is the lead sponsor of 70 studies on the registry; 26 are open to participants now.
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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.
Procedure: PDT
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.
Procedure: RFA
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.
Procedure: RFA combined with PDT
RFA will be performed
Also known as: ERCP guided
PDT will be performed
Also known as: ERCP guided
RFA and PDT will be performed
Also known as: ERCP guided
Overall survival (OS)
OS was defined as the time from initial RFA or PDT to death or the end of the study.
Time frame: Three years
Adverse events
Number of patients with adverse events
Time frame: Three years
Progression-free survival(PFS)
PFS was measured from therapy until the date of disease progression or death
Time frame: Three years
Plan to share: Undecided — Yet not decided
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First People's Hospital of Hangzhou