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Patient Outcomes After Hepatic Artery Infusion Pump Placement

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05468593
Collaborator
(none)
50
Enrollment
1
Location
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the surgical outcomes and the quality of life (QOL) in patients undergoing hepatic artery infusion pump placement for colorectal liver metastases (CRLM).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement
    Actual Study Start Date :
    Jul 12, 2022
    Anticipated Primary Completion Date :
    Jul 12, 2024
    Anticipated Study Completion Date :
    Jul 12, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life [Baseline prior to surgery.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    2. Quality of Life [Postoperative day 2.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    3. Quality of Life [Postoperative day 7.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    4. Quality of Life [Postoperative day 14.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    5. Quality of Life [Postoperative day 30.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    6. Quality of Life [Postoperative day 60.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    7. Quality of Life [Postoperative day 90.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    8. Quality of Life [Postoperative day 120.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    9. Quality of Life [Postoperative day 150.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    10. Quality of Life [Postoperative day 180.]

      Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.

    Secondary Outcome Measures

    1. Time to start chemotherapy [1 month postoperatively]

      Number of days following hepatic artery infusion pump placement until chemotherapy is started

    2. Surgical outcomes [1 month postoperatively]

      Complications with hepatic artery infusion pump placement

    3. Surgical outcomes [6 month postoperatively]

      Complications with hepatic artery infusion chemotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.

    • Written consent.

    Exclusion Criteria:

    • Absence of written consent.

    • Systemic disease.

    • Pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Cornelius Thiels, DO, MBA, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cornelius A. Thiels, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05468593
    Other Study ID Numbers:
    • 22-003190
    First Posted:
    Jul 21, 2022
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cornelius A. Thiels, Principal Investigator, Mayo Clinic
    Hepatic Artery Infusion
    Pump
    Hepatic Artery Infusion Chemotherapy
    Unresectable Colorectal Liver Metastases
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Jul 21, 2022