Efficacy of endobiliary radiofrequency in patients with inoperable hilar cholangiocarcinoma: A randomized controlled trial
- Conditions
- Neoplasms
- Registration Number
- KCT0008576
- Lead Sponsor
- Soon Chun Hyang University Hospital Bucheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to recurrent biliary obstruction
- Secondary Outcome Measures
Name Time Method Technical success;Clinical success;Adverse event;Overall survival