Patient Outcomes After Hepatic Artery Infusion Pump Placement

Colorectal Cancer Clinical Trial

Official title:

Patient Reported Outcomes After Hepatic Artery Infusion Pump Placement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468593
• Other study ID #: 22-003190
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Liver Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials