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

Colorectal Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164419
• Other study ID #: 2017-1611
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Stage IV
• Neoplasm Metastasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Patient is dead or aline	2 years
Secondary	Local recurrence	Advent of recurrence in the liver parenchyma, measured by any time of medical imaging	2 years
Secondary	Distant recurrence	Advent of recurrence anywhere other than liver, measured by any time of medical imaging	2 years