The Characteristics of CRLM Patients Who Would Benefit More From Anatomical ResectionNCT05673564
Anatomical Resection in Colorectal Liver Metastases Patients
An observational study of The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection, run by Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection
- What is being tested?
- Anatomical Resection
- Type of treatment
- Surgery or procedure
- How many people
- 729 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (1)Age 18-79 years;(2) Histologically proven colorectal adenocarcinoma;
Who cannot join
- 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.
About this study
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.
- Being tested
- Anatomical Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical ResectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
Relapse-free survival since patients undergoing hepatic resection
Measured: 2012.6.1-2022.6.1
Secondary outcomes (1)
OS
Overall survival since patients undergoing hepatic resection
Measured: 2012.6.1-2022.6.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jun 2012
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Characteristics of CRLM Patients Who Would Benefit More From Anatomical ResectionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673564
- Sponsor's protocol ID
- ARCRLM
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Resection in Colorectal Liver Metastases Patients
- ClinicalTrials.gov ID
- NCT05673564
- Acronym / sponsor ID
- ARCRLM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anatomical resection group | – | Procedure: Anatomical ResectionAnatomical 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. |
| 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (1)Age 18-79 years;(2) Histologically proven colorectal adenocarcinoma;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical ResectionBased 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. | Procedure or surgery | anatomical resection group |
Primary outcome
RFS
Time frame: 2012.6.1-2022.6.1
Relapse-free survival since patients undergoing hepatic resection
1 secondary outcome
OS
Time frame: 2012.6.1-2022.6.1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of The Characteristics of CRLM Patients Who Would Benefit More From Anatomical Resection, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (time frame: 2012.6.1-2022.6.1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.