NCT05468593

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 12, 2022

Last Update Submit

July 29, 2024

Conditions

Colorectal Liver MetastasesColorectal Cancer

Keywords

Hepatic Artery InfusionPumpHepatic Artery Infusion ChemotherapyUnresectable Colorectal Liver Metastases

Outcome Measures

Primary Outcomes (10)

  • 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 Outcomes (3)

  • Time to start chemotherapy

    1 month postoperatively

  • Surgical outcomes

    1 month postoperatively

  • Surgical outcomes

    6 month postoperatively

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients who receive a Hepatic Artery Infusion Pump at Mayo Clinic Rochester for liver metastases from colorectal cancer.
  • Written consent.

You may not qualify if:

  • Absence of written consent.
  • Systemic disease.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Cornelius Thiels, DO, MBA

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 21, 2022

Study Start

July 12, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)