RecruitingNot ApplicableNCT06168292

Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma

Intraductal Radiofrequency Thermoablation and Radiotherapy Combined Treatment for Extrahepatic Cholangiocarcinoma: A Prospective, Single-arm, Multicenter Study


Sponsor

National Cancer Center, Korea

Enrollment

53 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 cholangiocarcinoma.


Eligibility

Min Age: 20 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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)

Interventions

PROCEDUREID-RFA and Radiotherapy

The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.


Locations(1)

National Cancer Center, Korea

Goyang-si, Other, South Korea

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NCT06168292


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