Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
- Conditions
- Intrahepatic Cholangiocarcinoma
- Registration Number
- NCT02878473
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Eastern Cooperative Oncology Group: 0 or 1 at all times prior to Liver<br> Transplantation<br><br> - Absence of cancer-related symptoms<br><br> - Liver cirrhosis (any etiology)<br><br> - Patient not eligible for liver resection due to poor liver function/portal<br> hypertension<br><br> - Biopsy proven very early intrahepatic cholangiocarcinoma (iCCA)<br><br> - Willing and able to provide written informed consent.<br><br> - Negative serum pregnancy test for women of childbearing potential<br><br> - Biopsy proven very early (single =2 cm) iCCa<br><br> - No vascular or biliary involvement seen in preoperative imaging<br><br> - No extra-hepatic disease seen in preoperative imaging<br><br> - Carbohydrate Antigen (CA) 19.9 values are =100 ng/mL<br><br>Exclusion Criteria:<br><br> - Previous or concurrent cancer (with some exceptions)<br><br> - Patients that have had previous liver resection for iCCA and the current tumor is a<br> recurrence.<br><br> - Progression of the tumor in size >3 cm or development of extrahepatic disease.<br><br> - Large vessel invasion, defined radiologically.<br><br> - Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min<br><br> - Pulmonary insufficiency<br><br> - History of cardiac disease:<br><br> - Uncontrolled infection(s)<br><br> - Known history of human immunodeficiency virus (HIV) infection.<br><br> - History of solid organ transplantation<br><br> - Any condition that is unstable or which could jeopardize the safety of the patient<br> and his/her compliance in the study<br><br> - Pregnant or breast-feeding patients
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5 year patient survival
- Secondary Outcome Measures
Name Time Method disease recurrence after liver transplantation