Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan
ClinicalTrials.gov Identifier:
NCT01683357
First received: September 4, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Liver Metastases
Procedure: Hepatectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • feasibility on an intention-to-treat basis [ Time Frame: at the time of surgical intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of the procedure [ Time Frame: At 30 and 90 postoperative days ] [ Designated as safety issue: Yes ]
    Peroperative morbidity and mortality as classified according with Dindo-Clavien classification (see ref.); Amount of intraoperative blood loss and blood transfusions.


Other Outcome Measures:
  • reliability of the procedure from an oncological standpoint [ Time Frame: 6-months of minimum follow-up for local recurrences; 5 years actuarial curves for overall survival and time to recurrence ] [ Designated as safety issue: No ]
    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.


Enrollment: 58
Study Start Date: September 2001
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Multiple Bilobar CLM
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.


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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with multiple (> or = to 4) and bilobar colorectal liver metastases

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01683357

Locations
Italy
Humanitas Cancer Center
Rozzano, Milano, Italy, 20089
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: Guido Torzilli, MD, PhD University of Milan, Humanitas Cancer Center
  More Information

Publications:

Responsible Party: Prof. Guido Torzilli, Director Liver Surgery Unit, Humanitas Cancer Center - Associate Professor, University of Milan, University of Milan
ClinicalTrials.gov Identifier: NCT01683357     History of Changes
Other Study ID Numbers: MTX-1STAGE LONG-TERM
Study First Received: September 4, 2012
Last Updated: September 6, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by University of Milan:
Liver Metastases
Surgery
Intraoperative Ultrasound

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 30, 2014