University of Michigan Transplant protocol

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    Copied from U-M website:

    Liver Transplantation
    In the past, cholangiocarcinoma was not considered as an indication for liver transplantation because 5-year survival for patients was only around 20%. Over the past 10 years, protocols have been developed that identify patients who have almost a 75% chance of surviving more than 5 years after a liver transplant has been performed. The University of Michigan is currently one of a handful of programs in the United States that has a United National Organ Sharing (UNOS) approved protocol that allows appropriate candidates to get a standard exception allowing improved access to deceased donor livers.

    Patients Eligible for Transplant Include:

    Hilar cholangiocarcinoma (a tumor at the branching of the bile duct to the right and left side of the liver) that cannot be removed by surgery and is less than 3 cm wide in diameter.
    Cholangiocarcinoma is diagnosed as a malignant appearing stricture above the level of the cystic duct (branch of the bile duct going to the gall bladder) and has at least one of the following:
    CA 19-9 > 100 ng/ml
    Brushing of bile duct by ERCP or PTC demonstrating cancer cells
    A tumor seen on CT or MRI < 3 cm and suspicious for cholangiocarcinoma
    Patients who are otherwise a candidate for liver transplantation based on hepatology, surgery, and social work evaluation
    Patients Not Eligible for Transplant Include:

    Spread of cancer (metastases) to the liver, lymph nodes, or any other part of the body
    Cholangiocarcinoma in an area of the bile duct inside the liver or below the cystic duct
    Prior attempt at removal by surgery (this increases the chance the tumor may spread if it is not completely removed)
    Tumors that are >3cm in diameter when measured on CT or MRI
    Previous treatment with chemotherapy or radiation therapy
    Prior needle biopsy, either through the skin or by endoscopy, of the main tumor (this increases the risk for spread of the tumor outside of the bile duct). Lymph nodes surrounding the bile duct may be biopsied to ensure the tumor has not spread.
    Uncontrolled infection

    Steps for Evaluation, Pre-Transplant Treatment, and Liver Transplantation

    Patients who cannot be treated by removal of the tumor alone but fit the criteria for transplant will undergo a series of steps to be sure the tumor has not spread, to treat the tumor before (called neo-adjuvant therapy) transplant, followed by liver transplantation. The steps include:

    Evaluation for possible surgical resection in the University of Michigan Liver Tumor Clinic and presentation at the Multidisciplinary liver tumor board. This may require other tests including a liver MRI, chest CT, ERCP or PTC, etc.
    Evaluation for liver transplant by a hepatologist, social worker, and surgeon
    Biopsy (called fine needle aspiration – FNA) of the lymph nodes (not the actual tumor) by endoscopic ultrasound (EUS).
    Begin stereotactic body radiation therapy (SBRT) for 2-3 weeks
    Begin a chemotherapy oral medication called capecitabine and continue until transplant
    Exploratory surgery using a small incision or laparoscopy in the operating room (OR staging) to biopsy lymph nodes to be sure the tumor has not spread
    List for deceased donor transplant
    Perform liver transplant when a deceased donor liver is available or if a living liver donor volunteers

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