Patient Outcomes After Hepatic Artery Infusion Pump Placement

Study Overview
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Brief Summary
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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).

Official Title
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Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Conditions
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Colorectal Liver Metastases, Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Artery Infusion, Pump, Hepatic Artery Infusion Chemotherapy, Unresectable Colorectal Liver Metastases