NCT02331641

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

9.8 years

First QC Date

December 29, 2014

Last Update Submit

January 5, 2015

Conditions

Colorectal Liver MetastasesColon Cancer

Keywords

hepatectomyhepatic resection

Outcome Measures

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)

    up to 90 days after surgery

Secondary Outcomes (1)

  • Long-term outcome (overall and disease-free survival)

    10 years

Study Arms (2)

Major hepatectomy (MH)

Patients who underwent MH for CLM instead of multiple minor hepatectomy (MMH)

Procedure: Hepatectomy

Multiple minor hepatectomy (MMH)

Patients who underwent MMH for CLM instead of MH

Procedure: Hepatectomy

Interventions

HepatectomyPROCEDURE

Removal of a part of the liver

Also known as: Hepatic resection
Major hepatectomy (MH)Multiple minor hepatectomy (MMH)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with colorectal liver metastases (CLM) that underwent hepatectomy.

You may qualify if:

  • Diagnosis of CLM

You may not qualify if:

  • Uncertain diagnosis
  • Lost at follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

December 29, 2014

First Posted

January 6, 2015

Study Start

January 1, 2005

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01