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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331641
• Other study ID #: MajorVsMinorHepatectomy
• Status: Completed
• Phase: N/A
• First received: December 29, 2014
• Last updated: January 5, 2015
• Start date: January 2005
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of CLM

Exclusion Criteria:

• Uncertain diagnosis

• Lost at follow-up

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Hepatectomy
Removal of a part of the liver

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of postoperative complications after MH or MMH, graded based on the Dindo's classification (Dindo et al. Ann Surg 2004;240:205-13)		up to 90 days after surgery	Yes
Secondary	Long-term outcome (overall and disease-free survival)	Typical follow-up after surgery (until death and evidence of recurrence)	10 years	No