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Completed

NCT Number: NCT05468593

Patient Outcomes After Hepatic Artery Infusion Pump Placement

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).

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Key information

Conditions

Colorectal Liver Metastases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quality of Life

    Time frame: 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

    Time frame: Postoperative day 2.

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

  3. Quality of Life

    Time frame: Postoperative day 7.

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

  4. Quality of Life

    Time frame: Postoperative day 14.

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

  5. Quality of Life

    Time frame: Postoperative day 30.

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

  6. Quality of Life

    Time frame: Postoperative day 60.

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

  7. Quality of Life

    Time frame: Postoperative day 90.

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

  8. Quality of Life

    Time frame: Postoperative day 120.

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

  9. Quality of Life

    Time frame: Postoperative day 150.

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

  10. Quality of Life

    Time frame: Postoperative day 180.

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

Secondary outcomes

  1. Time to start chemotherapy

    Time frame: 1 month postoperatively

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

  2. Surgical outcomes

    Time frame: 1 month postoperatively

    Complications with hepatic artery infusion pump placement

  3. Surgical outcomes

    Time frame: 6 month postoperatively

    Complications with hepatic artery infusion chemotherapy

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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