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Liver Transplantation for Early Intrahepatic Cholangiocarcinoma

Clinicaltrials.gov ID

NCT02878473

Status

Recruiting

Study Type

Interventional, Phase 2

Sponsor

University Health Network, Toronto

Start Date

4 avril 2018

Anticipated End Date

1 janvier 2026

Study Contact

Name: Erin Winter, BSC

Phone Number: 416-340-4800 ext 6093

Email: erin.winter@uhn.ca

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

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Le Collectif Canadien pour le cholangiocarcinome (C3) est financé par une subvention d'équipe révolutionnaire de la Société Canadienne du cancer en partenariat avec les Instituts de recherche en santé du Canada. Les fonds de la subvention pour le C3 sont gérés par l'Institut de recherche de l'Hôpital d'Ottawa, qui sert d'institut principal pour toutes les opérations collaboratives.

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