Status:

RECRUITING

Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma

Lead Sponsor:

National Cancer Center, Korea

Collaborating Sponsors:

Boston Scientific Corporation

Conditions:

Biliary Tract Carcinoma

Radiotherapy

Eligibility:

All Genders

20+ years

Phase:

NA

Brief Summary

\[Study objectives\] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholang...

Detailed Description

○ Study flow The clinical study will be conducted in the following order. Of patients with extrahepatic cholangiocarcinoma requiring biliary drainage, those who meet the inclusion criteria and consent...

Eligibility Criteria

Inclusion

  • Patients 20 years of age or older, who voluntarily agree to participate in the study and sign the informed consent.
  • Patients with cytopathologically diagnosed inoperable extrahepatic cholangiocarcinoma

Exclusion

  • Patients who refuse to sign the informed consent
  • Patients with metastatic cancer (stage IV) or malignant ascites
  • Patients with intrahepatic cholangiocarcinoma
  • Patients who are unable to undergo endoscopic procedures as determined by the investigator.
  • Patients with a life expectancy of 3 months or less
  • Patients with ID-RFA contraindications: pacemaker, pregnancy, uncorrected bleeding tendency (PT INR \> 1.5, platelets \< 50,000/mm3)

Key Trial Info

Start Date :

April 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2030

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT06168292

Start Date

April 1 2024

End Date

June 30 2030

Last Update

June 19 2025

Active Locations (1)

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1

National Cancer Center, Korea

Goyang-si, Other, South Korea, 10408