Patient Outcomes After Hepatic Artery Infusion Pump Placement

Patient Reported 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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Liver Metastases

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Cornelius A Thiels; Phone Number: 507-284-2095; Email: Thiels.Cornelius@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal liver metastases (CRLM) being offered Hepatic Artery Infusion Pump placement and subsequent Hepatic Artery Infusion Chemotherapy at Mayo Clinic Rochester will be evaluated to participate in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Baseline prior to surgery.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 2.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 7.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 14.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 30.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 60.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 90.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 120.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 150.
Quality of Life	Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.	Postoperative day 180.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to start chemotherapy	Number of days following hepatic artery infusion pump placement until chemotherapy is started	1 month postoperatively
Surgical outcomes	Complications with hepatic artery infusion pump placement	1 month postoperatively
Surgical outcomes	Complications with hepatic artery infusion chemotherapy	6 month postoperatively

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hepatic Artery Infusion; Pump; Hepatic Artery Infusion Chemotherapy; Unresectable Colorectal Liver Metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 22-003190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No