- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02331641
Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.
January 5, 2015 updated by: Prof. Guido Torzilli, University of Milan
Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases. A Propensity Score-matched Dual-institution Analysis.
The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in patients with colorectal liver metastases (CLM) is object of debate.
We build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to investigate the outcome of patients with colorectal liver metastases (CLM) undergoing multiple minor hepatectomies (MMH) instead of major hepatectomies (MH).
Indeed, the performance of MMH versus MH in patients with CLM is object of debate.
For this purpose, the databases at two independent institutions were retrospectively reviewed.
To control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used.
Among 554 patients, 110 patients undergoing MMH and 110 undergoing MH were matched.
They were similar in baseline characteristics, comorbidities, features of the primary tumors, and CLM.
Primary outcomes were short- and long-term outcome.
Study Type
Observational
Enrollment (Actual)
554
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with colorectal liver metastases (CLM) that underwent hepatectomy.
Description
Inclusion Criteria:
- Diagnosis of CLM
Exclusion Criteria:
- Uncertain diagnosis
- Lost at follow-up
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Major hepatectomy (MH)
Patients who underwent MH for CLM instead of multiple minor hepatectomy (MMH)
|
Removal of a part of the liver
Other Names:
|
|
Multiple minor hepatectomy (MMH)
Patients who underwent MMH for CLM instead of MH
|
Removal of a part of the liver
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of postoperative complications after MH or MMH, graded based on the Dindo's classification (Dindo et al. Ann Surg 2004;240:205-13)
Time Frame: up to 90 days after surgery
|
up to 90 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long-term outcome (overall and disease-free survival)
Time Frame: 10 years
|
Typical follow-up after surgery (until death and evidence of recurrence)
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2005
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
January 5, 2015
First Posted (Estimate)
January 6, 2015
Study Record Updates
Last Update Posted (Estimate)
January 6, 2015
Last Update Submitted That Met QC Criteria
January 5, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MajorVsMinorHepatectomy
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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