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Completed

NCT Number: NCT02331641

Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.

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.

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Key information

Conditions

Colorectal Liver Metastases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of CLM

Exclusion criteria

  • Uncertain diagnosis
  • Lost at follow-up

Treatment and study plan

Hepatectomy

Procedure

Removal of a part of the liver

Other names: Hepatic resection

Primary outcomes

  1. 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

Secondary outcomes

  1. Long-term outcome (overall and disease-free survival)

    Time frame: 10 years

    Typical follow-up after surgery (until death and evidence of recurrence)

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • University of Bologna

Registry information

Official study title

Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases. A Propensity Score-matched Dual-institution Analysis.

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2015
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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