Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases

Completed

• Conditions: Liver Metastases
• Interventions: Procedure: Hepatectomy

• Registration Number: NCT01683357
• Lead Sponsor: University of Milan

Brief Summary

It is not rare that two-stage hepatectomy for multiple bilobar colorectal liver metastases (CLM) be left incomplete because of disease progression or technical reasons. One-stage hepatectomy seems a feasible and safe alternative, however, long-term results are lacking. This study aims to provide evidence that one-stage hepatectomy compelling tumor exposure provides adequate long-term results with low risk of local recurrences.

Detailed Description

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:

1. the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months;

2. 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).

3. 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.

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2012-03
• Study Completion: 2012-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-04
• Study First Submitted QC: 2012-09-06
• Last Update Submitted: 2012-09-06
• Study First Posted: 2012-09-11
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Bilobar CLM	Hepatectomy	Patients selected for hepatectomy because carrier of multiple (\> or = to 4), bilobar CLM

Primary Outcome Measures

Name	Time	Method
feasibility on an intention-to-treat basis	at the time of surgical intervention

Secondary Outcome Measures

Name	Time	Method
safety of the procedure	At 30 and 90 postoperative days	Peroperative morbidity and mortality as classified according with Dindo-Clavien classification (see ref.); Amount of intraoperative blood loss and blood transfusions.

Trial Locations

Locations (1)

Humanitas Cancer Center; 🇮🇹 Rozzano, Milano, Italy