Status:
TERMINATED
Liver Transplantation for Cholangiocarcinoma
Lead Sponsor:
University of Utah
Conditions:
Cancer
Cholangiocarcinoma
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Today, available therapies for hilar cholangiocarcinomas (CCA) are not satisfactory. Although these tumors are rare, their study is important because of the high death rates in afflicted patients, riv...
Detailed Description
Objectives Specific Aim #1: Determine whether results obtained in select patients with American Joint Commission on Cancer (AJCC) Staging System Stage I or II CCA are transferable to select patients w...
Eligibility Criteria
Inclusion
- The surgical protocol will initially be offered to liver transplant candidates with de novo hilar CCA or CCA arising in the setting of PSC. Diagnosis of CCA will be established by intraluminal brush cytology, intraluminal biopsy, or a carcinoma antigen (CA) 19.9 level greater than 100 ng / mL in the setting of a radiographic malignant stricture.
- Biliary aneuploidy demonstrated with DIA and FISH will be considered equivalent to cytology.
- All patients with CCA will be evaluated by the liver transplant team which includes experienced hepatobiliary and liver transplant surgeons. Patients will be presented at the weekly liver transplant selection conference to assess their candidacy as well as the weekly GI Multidisciplinary Tumor Conference at the Huntsman Cancer Institute. Clinical staging prior to neoadjuvant therapy will include chest and abdominal computed tomography, liver ultrasound, and bone scan. Patients will also undergo endoscopic ultrasound with fine needle aspiration of suspicious lymph nodes.
- All patients will undergo staging laparoscopy to rule out the presence of peritoneal disease followed by staging laparotomy.
- Patients with N1 disease (metastasis to lymph nodes within hepatoduodenal ligament) will remain eligible for the protocol.
- Tumor size will not be included in the exclusion criteria. Patients with evidence of disease progression beyond study criteria will not be eligible to continue on to liver transplantation.
- \*\* Patients with metastatic disease are not eligible for this trial \*\*
- Exclusion criteria will include:
- previous chemotherapy or radiotherapy,
- uncontrolled infection,
- a previous malignance other than non-melanoma skin cancer or in situ cervical cancer within the last five years,
- medical conditions precluding transplantation,
- metastatic disease (including N2 disease), and
- patients with hilar tumors extending below the cystic duct.
- Patients with extrahepatic metastases, local spread of disease to adjacent organs, and N2 nodal disease (metastasis to peripancreatic, periduodenal, periportal, celiac, superior mesenteric, and / or posterior pancreaticoduodenal nodes) will be excluded as will patients with extension of tumor into the main portal vein.
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00708877
Start Date
March 1 2007
End Date
July 1 2011
Last Update
July 30 2013
Active Locations (1)
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1
University of Utah/Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112