Colorectal Cancer Clinical Trial
Official title:
Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement
NCT number | NCT05468593 |
Other study ID # | 22-003190 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 12, 2022 |
Est. completion date | July 2024 |
Verified date | July 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Baseline prior to surgery. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 2. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 7. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 14. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 30. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 60. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 90. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 120. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 150. | |
Primary | Quality of Life | Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time. | Postoperative day 180. | |
Secondary | Time to start chemotherapy | Number of days following hepatic artery infusion pump placement until chemotherapy is started | 1 month postoperatively | |
Secondary | Surgical outcomes | Complications with hepatic artery infusion pump placement | 1 month postoperatively | |
Secondary | Surgical outcomes | Complications with hepatic artery infusion chemotherapy | 6 month postoperatively |
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