Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques

May 29, 2023 updated by: Université de Sherbrooke
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Main objective : evaluation the margin status (<1mm, 1-4mm, 5-9mm, >10mm) on the survival and recurrence in colo-rectal liver metastases surgery.

Secondary objectives include :

Evaluate potentiel effects of neo-adjuvant chemotherapy, portal embolisation, and evaluate potentiel bias such as size and number of liver metastases, TNM status of original tumor, timing between primary and metastasis, and extra-hepatic disease.

Methods :

A retrospective cohort study is built where all patients undergoing liver surgery for colorectal liver metastases between 2011 and 2015 are analysed. Subjects are separated in groups according to their margin status. The local and distal recurrence rates are measured and well as survival. Data is obtained through our hospital data management system. Inclusion criterias include age over 18, primary colorectal cancer metastatic to the liver, having undergone surgery between 2011 and 2015, available pathology reports with required data, available radiologic follow-up. Exclusion criterias include repeat liver resection, documented grossly positive margins (R2 resection), and unavailable pathologic information and follow-up. Using survival as primary outcome (Kaplan Meier) and considering 25% potential loss to follow-up, we calculated a sample size. Since this a retrospective study, no patient is directly contacted. Data will is handled by the surgery resident responsible for the project as well as by research assistants. Statistical analysis are performed accordingly.

Study Type

Observational

Enrollment (Actual)

170

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

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Repeat liver resection No tissu or incomplete pathological information

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
Patient is dead or aline
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence
Time Frame: 2 years
Advent of recurrence in the liver parenchyma, measured by any time of medical imaging
2 years
Distant recurrence
Time Frame: 2 years
Advent of recurrence anywhere other than liver, measured by any time of medical imaging
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

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)

January 1, 2006

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1611

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.

Clinical Trials on Colorectal Cancer Stage IV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe