NCT05164419

Brief Summary

We retrospectively looks at the impact of the margin status and its size in mm on the recurrence rate in colo-rectal liver metastasis surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2006

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

11 years

First QC Date

December 7, 2021

Last Update Submit

May 29, 2023

Conditions

Colorectal Cancer Stage IV

Keywords

liver surgeryColorectal liver metastasis

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Patient is dead or aline

    2 years

Secondary Outcomes (2)

  • Local recurrence

    2 years

  • Distant recurrence

    2 years

Study Arms (2)

Wide margin

Patients who underwent surgery with a final pathologic margin of more than 5mm.

Close margin

Patients who underwent surgery with a final pathologic margin of less than 5mm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with colorectal liver metastases undergoing liver resection at our institution during the defined time-frame.

You may qualify if:

  • Primary colorectal cancer with liver metastasis
  • Undergone liver surgery at our center between 2011 and 2015
  • Pathological reports with margin status available (or specimen still available for measurement)

You may not qualify if:

  • Repeat liver resection No tissu or incomplete pathological information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

January 1, 2006

Primary Completion

December 31, 2016

Study Completion

December 31, 2019

Last Updated

May 31, 2023

Record last verified: 2023-05