An observational study in Liver Metastases, sponsored by University of Milan. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2012-09-11.
Sponsored by University of Milan · Observational
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.
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:
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 58 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
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Patients with multiple (> or = to 4) and bilobar colorectal liver metastases
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
Patients selected for hepatectomy because carrier of multiple (\> or = to 4), bilobar CLM
Procedure: Hepatectomy
Intraoperative ultrasound (IOUS) criteria for tumor-vessel relations let maximizing the preservation of the hepatic vascular skeleton. Contact between colorectal liver metastases and a major intrahepatic vessel is not by itself a criteria for vessel resection: tumor exposure is not contraindicated. If resection of a hepatic vein (HV), resection of the liver parenchyma drained by that vein is considered or not based on color-flow IOUS findings (hepatofugal blood flow in the feeding portal branch, evidence or not of communicating veins between adjacent HVs, evidence or not of accessory HVs). Parenchymal transection is performed under intermittent clamping by the Pringle maneuver. Drains are always inserted and a chest tube is inserted in patients undergoing thoracophrenolaparotomy.
feasibility on an intention-to-treat basis
Time frame: at the time of surgical intervention
safety of the procedure
Peroperative morbidity and mortality as classified according with Dindo-Clavien classification (see ref.); Amount of intraoperative blood loss and blood transfusions.
Time frame: At 30 and 90 postoperative days
reliability of the procedure from an oncological standpoint
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.
Time frame: 6-months of minimum follow-up for local recurrences; 5 years actuarial curves for overall survival and time to recurrence
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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University of Milan