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Liver Transplantation for Cholangiocarcinoma


N/A
16 Years
N/A
Not Enrolling
Both
Cancer, Cholangiocarcinoma, Liver

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Trial Information

Liver Transplantation for Cholangiocarcinoma


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 with T3 or N1 disease.

Specific Aim #2: To determine whether success achieved with the only published protocol
currently in use is directly transferable to the University of Utah's liver transplant
program.

Liver Transplant Protocol:

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. 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.

All patients will undergo staging laparoscopy to rule out the presence of peritoneal disease
followed by staging laparotomy. 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. 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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Transplant-related Mortality

Outcome Description:

Determined mortality-related transplant outcomes.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Jason Schwartz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Institutional Review Board

Study ID:

HCI18450

NCT ID:

NCT00708877

Start Date:

March 2007

Completion Date:

July 2011

Related Keywords:

  • Cancer
  • Cholangiocarcinoma
  • Liver
  • cancer
  • cholangiocarcinoma
  • Cholangiocarcinoma

Name

Location

University of Utah/Huntsman Cancer InstituteSalt Lake City, Utah  84112