Trial Information

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

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.