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

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:
  • Hepatic resection
Multiple minor hepatectomy (MMH)
Patients who underwent MMH for CLM instead of MH
Removal of a part of the liver
Other Names:
  • Hepatic resection

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.

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

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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