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CompletedNCT05673564Updated Jan 6, 2023

Anatomical Resection in Colorectal Liver Metastases Patients

An observational study in The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection, sponsored by Fudan University. Completed. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-01-06.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
729
Ages
18 Years to 79 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection

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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 729 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

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Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
729 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

Interventions

  • ProcedureAnatomical 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.

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What researchers measure

Primary outcomes

  1. RFS

    Relapse-free survival since patients undergoing hepatic resection

    Time frame: 2012.6.1-2022.6.1

Secondary outcomes

  1. OS

    Overall survival since patients undergoing hepatic resection

    Time frame: 2012.6.1-2022.6.1

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05673564
Lead sponsor
Fudan University
Responsible party
Xu jianmin (Head of Colorectal Surgery, Fudan University) — Principal investigator
First posted
Jan 6, 2023
Start date
Jun 1, 2012
Primary completion
May 1, 2019
Completion
May 1, 2019
Last update
Jan 6, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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