Treat Primary and Metastatic Liver Tumors

Sponsor
Methodist Health System (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05240040
Collaborator
(none)
100
1
72.1
1.4

Study Details

Study Description

Brief Summary

The use of Radiospheres in the management of intrahepatic cholangiocarcinoma is largely unknown and not reported in the medical literature. Methodist Dallas Medical Center has a large volume of IR procedures with Radioembolization and the investigators feel it is imperative to understand the outcomes, risks and benefits of the therapy in order to formulate recommendation to other centers.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A retrospective chart review of patients who have the diagnosis of intrahepatic cholangiocarcinoma. Only patients treated at MDMC are included and data will be obtained from Meditech and Epic. A non-identified database of cases with the diagnosis of intrahepatic cholangiocarcinoma already treated with radiospheres will be created and compared with cases treated by other means.

    Intrahepatic cholangiocarcinoma is the second most common primary malignancy of the liver. The standard therapy has been resection but many cases are not resectable due to comorbidities or other poor surgical candidacy factors. Most of these patients end up getting chemotherapy which can be toxic and sometimes poorly tolerated. Intrarterial glass or resin radioembolization has been used and published from only 3 centers in the medical literature and it has been shown to be a reasonable alternative to the above options. At MDMC, this therapy has been used effectively and it is important to describe the investigator's experience.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Radioembolization to Treat Primary and Metastatic Liver Tumors
    Actual Study Start Date :
    Apr 26, 2016
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    May 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. review the outcomes of patients treated with radiospheres [January 2006 until April 2017]

      Patient survival

    2. time to recurrence [January 2006 until April 2017]

      time to recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with the diagnosis of intrahepatic cholangiocarcinoma from January 2006 until April 2017 at Methodist Dallas Medical Center (MDMC)

    • Patients 18 years old or older

    Exclusion Criteria:
    • Patients without the diagnosis of intrahepatic cholangiocarcinoma

    • Patients under 18 years of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    • Principal Investigator: Alejandro Mejia, MD, Methodist Dallas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT05240040
    Other Study ID Numbers:
    • 029.HPB.2016.D
    First Posted:
    Feb 15, 2022
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Methodist Health System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 15, 2022