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Efficacy of endobiliary radiofrequency in patients with inoperable hilar cholangiocarcinoma: A randomized controlled trial

Efficacy of endobiliary radiofrequency in patients with inoperable hilar cholangiocarcinoma: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008576
Enrollment
55
Registered
2023-06-28
Start date
2022-06-06
Completion date
Unknown
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : We tried to determine the procedural success rate and adverse events of endobiliary RFA in patients with inoperable hilar cholangiocarcinoma. Prior to the procedure, we collected d

Sponsors

Soon Chun Hyang University Hospital Bucheon
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients 19 years of age or older 2) Histopathologically confirmed hilar cholangiocarcinoma 3) Segmental bile duct stricture within 1 cm of the hepatic portal segment 4) Unresectable, the patient is at high risk for surgery, or the patient is unwilling to undergo surgery 5) Predicted survival is greater than or equal to 3 months 6) Performance status: ECOG 0 to 1 or Karnofsky performance >80% 7) Consent to participate in this study and have completed an informed consent form

Exclusion criteria

Exclusion criteria: 1) Malignant hilar biliary stricture caused by a disease other than biliary cancer 2) Patients who are ineligible for cholangiopancreatography (ERCP) 3) Patients with uncontrolled coagulation disorders (PT-INR > 1.5, normal 0.85-1.25 or platelet count < 60,000/mm3, normal 150,000-450,000/mm3) 4) Patients who are unable to discontinue dual anti-platelet agents (e.g., patients with coronary artery disease who have undergone a coronary stenting procedure within 6 months). 5) Patients with surgically altered anatomy of the biliary tract 6) Patients who are pregnant or lactating 7) Patients who do not agree to participate in this study

Design outcomes

Primary

MeasureTime frame
Time to recurrent biliary obstruction

Secondary

MeasureTime frame
Technical success;Clinical success;Adverse event;Overall survival

Countries

Korea, Republic of

Contacts

Public ContactIl Sang Shin

Soon Chun Hyang University Hospital Bucheon

110554@schmc.ac.kr+82-32-621-5094

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026