NCT05519319

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not 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.

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.

Conditions

• Extrahepatic Cholangiocarcinoma
• Bile Duct Cancer

Interventions

Type	Name	Description
PROCEDURE	RFA	RFA will be performed
PROCEDURE	PDT	PDT will be performed
PROCEDURE	RFA combined with PDT	RFA and PDT will be performed

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-31
• Completion: 2026-06-01
• First posted: 2022-08-29
• Last updated: 2023-02-21

Locations

1 site across 1 country: China