Clinical trial NCT05164419: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer Stage IV
Keywords: liver surgery
Colorectal liver metastasis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with colorectal liver metastases undergoing liver resection at our institution during the defined time-frame.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Local recurrence
timeFrame: 2 years
measure: Distant recurrence
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
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