Prognosis of One-stage Hepatectomy for Bilobar Colorectal Metastases - Full Text View

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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.

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:

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

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:

Torzilli G, Procopio F, Botea F, Marconi M, Del Fabbro D, Donadon M, Palmisano A, Spinelli A, Montorsi M. One-stage ultrasonographically guided hepatectomy for multiple bilobar colorectal metastases: a feasible and effective alternative to the 2-stage approach. Surgery. 2009 Jul;146(1):60-71.

Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28.

Torzilli G, Garancini M, Donadon M, Cimino M, Procopio F, Montorsi M. Intraoperative ultrasonographic detection of communicating veins between adjacent hepatic veins during hepatectomy for tumours at the hepatocaval confluence. Br J Surg. 2010 Dec;97(12):1867-73. doi: 10.1002/bjs.7230. Epub 2010 Aug 26.

Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46.

Torzilli G, Palmisano A, Procopio F, Cimino M, Botea F, Donadon M, Del Fabbro D, Montorsi M. A new systematic small for size resection for liver tumors invading the middle hepatic vein at its caval confluence: mini-mesohepatectomy. Ann Surg. 2010 Jan;251(1):33-9.

Torzilli G, Procopio F, Donadon M, Del Fabbro D, Cimino M, Montorsi M. Safety of intermittent Pringle maneuver cumulative time exceeding 120 minutes in liver resection: a further step in favor of the "radical but conservative" policy. Ann Surg. 2012 Feb;255(2):270-80.

Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11.

Torzilli G, Del Fabbro D, Palmisano A, Donadon M, Bianchi P, Roncalli M, Balzarini L, Montorsi M. Contrast-enhanced intraoperative ultrasonography during hepatectomies for colorectal cancer liver metastases. J Gastrointest Surg. 2005 Nov;9(8):1148-53; discussion 1153-4.

Wicherts DA, Miller R, de Haas RJ, Bitsakou G, Vibert E, Veilhan LA, Azoulay D, Bismuth H, Castaing D, Adam R. Long-term results of two-stage hepatectomy for irresectable colorectal cancer liver metastases. Ann Surg. 2008 Dec;248(6):994-1005.

Adam R, Laurent A, Azoulay D, Castaing D, Bismuth H. Two-stage hepatectomy: A planned strategy to treat irresectable liver tumors. Ann Surg. 2000 Dec;232(6):777-85.

Narita M, Oussoultzoglou E, Jaeck D, Fuchschuber P, Rosso E, Pessaux P, Marzano E, Bachellier P. Two-stage hepatectomy for multiple bilobar colorectal liver metastases. Br J Surg. 2011 Oct;98(10):1463-75. doi: 10.1002/bjs.7580. Epub 2011 Jun 28.

Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51.

Minagawa M, Makuuchi M, Torzilli G, Takayama T, Kawasaki S, Kosuge T, Yamamoto J, Imamura H. Extension of the frontiers of surgical indications in the treatment of liver metastases from colorectal cancer: long-term results. Ann Surg. 2000 Apr;231(4):487-99.

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

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 May 22, 2013