Anatomical Resection in Colorectal Liver Metastases Patients

Sponsor

Fudan University (Other)

Overall Status

Completed

CT.gov ID

NCT05673564

Collaborator

(none)

729

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection	Procedure: Anatomical Resection

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 Design

Study Type:

Observational

Actual Enrollment :

729 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Anatomical Resection in Colorectal Liver Metastases Patients

Actual Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	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.	Procedure: Anatomical Resection 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.

Arm

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.

Procedure: Anatomical Resection

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.

Outcome Measures

Primary Outcome Measures

RFS [2012.6.1-2022.6.1]
Relapse-free survival since patients undergoing hepatic resection

Secondary Outcome Measures

OS [2012.6.1-2022.6.1]
Overall survival since patients undergoing hepatic resection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xu jianmin, Head of Colorectal Surgery, Fudan University

ClinicalTrials.gov Identifier:

NCT05673564

Other Study ID Numbers:

ARCRLM

First Posted:

Jan 6, 2023

Last Update Posted:

Jan 6, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Jan 6, 2023