Liver Transplantation for Early Intrahepatic Cholangiocarcinoma
Clinicaltrials.gov ID
NCT02878473
Status
Recruiting
Study Type
Interventional, Phase 2
Sponsor
University Health Network, Toronto
Start Date
April 4, 2018
Anticipated End Date
January 1, 2026
Study Contact
About the Study
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due to historically poor results. Two retrospective evaluations have shown a 5 year survival \\~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This suggests that LT can be a curative treatment if applied selectively. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for resection) currently have no other curative treatment options. Participants will be allowed bridging therapies prior to receiving transplant. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.
Conditions
Intrahepatic Cholangiocarcinoma
Inclusion/Exclusion Criteria?
Primary, Secondary, Other Outcome Measures??
Locations in Canada
University Health Network, Toronto, Ontario, M5G 2C4, Canada
About the Study
Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is increasingly common in patients with liver cirrhosis, but these patients are denied liver transplantation (LT) by most centres due to historically poor results. Two retrospective evaluations have shown a 5 year survival \\~65% in selected patients with an iCCA diagnosis at the pathology of the explanted liver. This suggests that LT can be a curative treatment if applied selectively. This study will evaluate the effectiveness of LT as a treatment for very early iCCA diagnosed in cirrhotic patients who meet the strict selection criteria. Patients with advanced cirrhosis (not candidates for resection) currently have no other curative treatment options. Participants will be allowed bridging therapies prior to receiving transplant. Participants will be followed for 5 years from the time of transplant with patient survival and disease recurrence as outcome measures.
Conditions
Intrahepatic Cholangiocarcinoma
Interventions
PROCEDURE:
Deceased donor Liver Transplantation
Locations in Canada
University Health Network, Toronto, Ontario, M5G 2C4, Canada