Colorectal Liver MetastasesNCT05468593
Patient Outcomes After Hepatic Artery Infusion Pump Placement
An observational study of Colorectal Liver Metastases and Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastases, Colorectal Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.
- Written consent.
Who cannot join
- Absence of written consent.
- Systemic disease.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Colorectal Liver Metastases, Colorectal Cancer
- Keywords
- Hepatic Artery Infusion, Pump, Hepatic Artery Infusion Chemotherapy, Unresectable Colorectal Liver Metastases
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Baseline prior to surgery.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 2.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 7.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 14.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 30.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 60.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 90.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 120.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 150.
Quality of Life
Self-reported quality of life and recovery from surgery using a questionnaire to investigate changes over time.
Measured: Postoperative day 180.
Secondary outcomes (3)
Time to start chemotherapy
Number of days following hepatic artery infusion pump placement until chemotherapy is started
Measured: 1 month postoperatively
Surgical outcomes
Complications with hepatic artery infusion pump placement
Measured: 1 month postoperatively
Surgical outcomes
Complications with hepatic artery infusion chemotherapy
Measured: 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start12 Jul 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cornelius A. Thiels, Mayo Clinic
- Investigators
- Cornelius Thiels, DO, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468593
- Sponsor's protocol ID
- 22-003190
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement
- ClinicalTrials.gov ID
- NCT05468593
- Acronym / sponsor ID
- 22-003190
- Conditions
- Colorectal Liver Metastases, Colorectal Cancer
- Keywords
- Hepatic Artery Infusion, Pump, Hepatic Artery Infusion Chemotherapy, Unresectable Colorectal Liver Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.
- Written consent.
Key exclusion criteria (3 listed)
- Absence of written consent.
- Systemic disease.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Time to start chemotherapy
Time frame: 1 month postoperatively
Surgical outcomes
Time frame: 1 month postoperatively
Surgical outcomes
Time frame: 6 month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornelius Thiels, DO, MBA principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastases and Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Baseline prior to surgery.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.