Alternative to Two-Stage Hepatectomy - Full Text View

Sponsors and Collaborators:	University of Milan Fondazione Humanitas per la Ricerca
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00587756

Purpose

Two-stage hepatectomy with or without portal vein embolization allows to treat multiple bilobar metastases expanding surgical indications for these patients. However, it has some related drawbacks: two operations are needed, and some patients do not complete the treatment strategy for disease progression. Using experience gained from our ultrasound guided resection policy we explored the safety and effectiveness of one-stage surgical procedures in patients otherwise recommended for the two-stage approach.

Condition	Intervention
Colorectal Cancer Liver Metastases	Procedure: One-stage ultrasound guided hepatectomy

MedlinePlus related topics: Cancer Colorectal Cancer Surgery Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy

Further study details as provided by University of Milan:

Primary Outcome Measures:

The primary 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. [ Time Frame: 30-day and 90-day postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months. [ Time Frame: Minimum Follow-up of 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	19
Study Start Date:	September 2001
Study Completion Date:	December 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Prospective cohort of consecutive patients who undergo surgery for colorectal cancer liver metastases	Procedure: One-stage ultrasound guided hepatectomy Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.

Eligibility

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

Study Population

Patients carriers of colorectal cancer liver metastases

Criteria

Inclusion Criteria:

Patients presenting with resectable colorectal cancer liver metastases (CLM)
4 or more lesions
Bilobar involvement of the liver
Contact or close adjacency (less than 0.5 cm) of at least one CLM with major intrahepatic vascular structures (1st or 2nd order portal branches and/or hepatic vein at caval confluence).

Exclusion Criteria:

Patients with 3 or less resectable CLM
Patients with 4 or more resectable CLM but nor bilobar
Patients with 4 or more bilobar resectable CLM without any lesion presenting condition of point 4 of the inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587756

Locations

Italy
Istituto Clinico Humanitas - Irccs
ROZZANO - MILANO, Italy, 20089

Sponsors and Collaborators

University of Milan

Fondazione Humanitas per la Ricerca

Investigators

Principal Investigator:

Guido Torzilli, MD, PhD

University of Milan, Istituto Clinico Humanitas - IRCCS

More Information

Publications:

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.

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.

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, 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, 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.

Responsible Party:	University of Milan, Istituto Clinico Humanitas - IRCCS ( Prof. Guido Torzilli )
Study ID Numbers:	MTX-1STAGE, MTX-CRC-1STAGE
Study First Received:	January 3, 2008
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00587756 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by University of Milan:

intraoperative ultrasonography
colorectal liver metastases
hepatectomy
portal vein embolization
Liver

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Neoplasm Metastasis
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Liver Neoplasms

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009