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

September 4, 2012
September 6, 2012
September 2001
March 2012   (final data collection date for primary outcome measure)
feasibility on an intention-to-treat basis [ Time Frame: at the time of surgical intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683357 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases
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

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:

  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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Liver Metastases
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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
July 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01683357
MTX-1STAGE LONG-TERM
No
Prof. Guido Torzilli, University of Milan
University of Milan
Not Provided
Principal Investigator: Guido Torzilli, MD, PhD University of Milan, Humanitas Cancer Center
University of Milan
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP