Liver Transplantation for Cholangiocarcinoma

NCT00708877 | Terminated Results DMC

• 1 other identifier: HCI18450
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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, rivaling that of pancreatic cancer. Surgical resection offers the only current hope for long-term survival, averaging only 20% in major series1. The reality is such that for the majority of patients, CCA is a diagnosis of despair. Although surgery has offered the only hope of cure, one of the major limiting factors in achieving long-term survival following surgical resection of CCA is the technical ability to achieve negative resection margins. The presence of malignant cells at the surgical margins following resection is a major prognostic factor predicting recurrence and death. Theoretically, the likelihood of achieving negative margins can be increased with total hepatectomy and orthotopic liver transplantation (OLT). Previous experience with OLT performed in isolation for hilar CCA's has been discouraging with dismal survival rates. However, a recent report has demonstrated that long-term survival can occur in carefully selected patients by combining the benefits of radiotherapy, chemosensitization, and OLT. With this strategy, patients survival rates of 92%, 82%, and 82% at 1, 3, and 5 years after transplantation have been achieved. It is not clear that these preliminary results can be confirmed at other centers, nor is it clear what selection criteria should optimally be used for this treatment strategy. Our hypothesis is that select patients undergoing liver transplantation for CCA in the context of multi-modality neoadjuvant therapy exhibit survival equivalent to other established indications for liver transplantation as previously demonstrated. We will also attempt to extend previously published criteria for liver transplantation in the setting of CCA by offering this protocol to patients with evidence of intrahepatic disease and regional nodal disease. Patients undergoing transplantation for CCA will be followed longitudinally for their entire post-transplant course and compared with a matched cohort of liver transplant recipients in regard to post-transplant survival, survival on the waiting list, as well as complications pre-and post-transplantation. Explanted livers will be examined for the presence of residual tumor. Data will be collected on the rate of regional lymph node metastasis, invasion of adjacent organs and tissues, and the rate of peritoneal metastases. The rate of tumor recurrence, site, and time to recurrence will also be assessed.

Conditions

Cancer; Cholangiocarcinoma; Liver

Keywords

cancer; cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Transplant-related Mortality

  Determined mortality-related transplant outcomes.

  2 years

Study Arms (1)

All participants

EXPERIMENTAL

Procedure: Liver Transplantation

Interventions

Liver Transplantation PROCEDURE

Transplantation will initially be performed with deceased donor livers using the technique of caval-sparing hepatectomy unless suspected caudate involvement or caudate atrophy is a concern regarding the resection margin. Patients will be assigned a provisional Model for End-Stage Liver Disease (MELD) score by the United Network for Organ Sharing (UNOS) Regional Review Board that will make a recipient eligible for transplantation within three months at the time of listing (typically 20-24). A segment of donor iliac artery will be used as an interposition graft to the recipient infrarenal aorta. The hilus will be avoided during dissection and the bile duct, hepatic artery, and portal vein will be divided as low as possible. A frozen section of the bile duct margin will be performed and patient will undergo pancreaticoduodenectomy if positive.

All participants

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \*\* Patients with metastatic disease are not eligible for this trial \*\*
• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah/Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms; Cholangiocarcinoma

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Results Point of Contact

• Title: Dr. Jason Schwarz
• Organization: University of Utah

jason.schwartz@hsc.utah.edu

8015852708

Study Officials

• Jason Schwartz, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 2, 2008
• Study Start: March 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 30, 2013
• Results First Posted: April 4, 2012

Record last verified: 2013-07

Locations

US (1)