Patient Outcomes After Hepatic Artery Infusion Pump Placement
July 29, 2024 updated by: Cornelius A. Thiels, Mayo Clinic
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
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
Time Frame: Baseline prior to surgery.
|
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
|
Baseline prior to surgery.
|
|
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.
|
Postoperative day 2.
|
|
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.
|
Postoperative day 7.
|
|
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.
|
Postoperative day 14.
|
|
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.
|
Postoperative day 30.
|
|
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.
|
Postoperative day 60.
|
|
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.
|
Postoperative day 90.
|
|
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.
|
Postoperative day 120.
|
|
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.
|
Postoperative day 150.
|
|
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.
|
Postoperative day 180.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to start chemotherapy
Time Frame: 1 month postoperatively
|
Number of days following hepatic artery infusion pump placement until chemotherapy is started
|
1 month postoperatively
|
|
Surgical outcomes
Time Frame: 1 month postoperatively
|
Complications with hepatic artery infusion pump placement
|
1 month postoperatively
|
|
Surgical outcomes
Time Frame: 6 month postoperatively
|
Complications with hepatic artery infusion chemotherapy
|
6 month postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cornelius Thiels, DO, MBA, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2022
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
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 30, 2024
Last Update Submitted That Met QC Criteria
July 29, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.