Completed

LONG-TERM RESULTS AFTER ONE-STAGE ULTRASOUND-GUIDED HEPATECTOMY IN PATIENTS WITH MULTIPLE BILOBAR COLORECTAL LIVER METASTASES: TOWARDS NEW CONCEPTS OF RADICAL RESECTION BY MEANS OF AN INTENTION TO TREAT ANALYSES

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What is being collected

Procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2001
See protocol details

Summary

Principal SponsorUniversity of Milan
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2001

Actual date on which the first participant was enrolled.

Eligibility Criteria The prospectively recruited cohort of patients herein analysed is the result of a policy for which those patients considered resectable and presenting 4 or more lesions, bilobar CLM were systematically approached in a one stage operation. Patients were considered unresectable once there was concomitance of more than 3 lung metastases, diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis. Outcome measures The primary outcome was the feasibility on an intention-to-treat basis. To this purpose we studied the ratio between the number of patients surgically explored and those who effectively received resection. The secondary outcome was the safety of the procedure. To this purpose we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests. The tertiary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the following: the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months; the long-term follow-up, analysing the overall survival (survival after surgery), time to recurrence (survival without recurrence), and time to liver recurrence (survival without liver recurrence). the overall survival compared with that based on an intention-to-treat criterion also including the outcome of those patients who met the inclusion criteria but resulted unresectable on exploration.

Principal SponsorUniversity of Milan
Last updated: September 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

58 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: Those patients considered resectable and presenting 4 or more CLM, involving both liver lobes are systematically approached in a one stage operation. Exclusion Criteria: Patients carriers of more than 3 lung metastases, and/or diffuse peritoneal carcinomatosis, and/or extra-hilar lymph node metastasis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Humanitas Cancer Center

Rozzano, ItalyOpen Humanitas Cancer Center in Google Maps
CompletedOne Study Center