Anatomical Resection in Colorectal Liver Metastases Patients

January 4, 2023 updated by: Xu jianmin, Fudan University
The type of liver resection (anatomical resection, AR or nonanatomical resection, NAR) for colorectal liver metastases (CRLM) is subject to debate. The debate may persist because some certain prognostic factors, associated with aggressive biological behavior of tumor, have been overlooked. The aim of our study was to investigate the characteristics of patients who would benefit more from anatomical resection for colorectal liver metastases.

Study Overview

Detailed Description

729 patients who underwent hepatic resection of CRLM were retrospectively collected from June 2012and May 2019. Treatment effects between AR and NAR were compared in full subgroup analyses. Tumor relapse-free survival (RFS) was evaluated by a stratified log-rank test and summarized with the use of Kaplan-Meier and Cox proportional hazards methods.

Study Type

Observational

Enrollment (Actual)

729

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 to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study was a retrospective cohort study based on our prospectively collected colorectal cancer database. All adult patients who underwent curative-intent liver resection for CRLM between June 2012 and May 2019 at Zhongshan Hospital in Shanghai and had available data on KRAS/NRAS/BRAF status, were eligible for inclusion.

Description

Inclusion Criteria:

(1)Age 18-79 years;(2) Histologically proven colorectal adenocarcinoma;

Exclusion Criteria:

(1) the histologic type of tumor was not called adenocarcinoma; (2) peritoneal metastasis; (3) number of liver metastasis >3; (4) simultaneous anatomical and nonanatomical resections; (5) R2 resection; (6) history of previous hepatectomy; (7) incomplete data. The rest of patients were divided into 2 groups: patients undergoing an AR, and patients undergoing a NAR.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
anatomical resection group
Anatomical resection was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these.
Based upon the segmental anatomy of the liver according to Couinaud system, AR was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these. NAR, known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.
nonanatomical resection group
Nonanatomical resection known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS
Time Frame: 2012.6.1-2022.6.1
Relapse-free survival since patients undergoing hepatic resection
2012.6.1-2022.6.1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 2012.6.1-2022.6.1
Overall survival since patients undergoing hepatic resection
2012.6.1-2022.6.1

Collaborators and Investigators

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

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)

June 1, 2012

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ARCRLM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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