Alternative to Two-Stage Hepatectomy

One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Procedure: One-stage ultrasound guided hepatectomy

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Italy
  • Rozzano - Milano, Italy, 20089
    • Istituto Clinico Humanitas - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients carriers of colorectal cancer liver metastases

Description

Inclusion Criteria:

1. Patients presenting with resectable colorectal cancer liver metastases (CLM)
2. 4 or more lesions
3. Bilobar involvement of the liver
4. 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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	30-day and 90-day postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	Minimum Follow-up of 6 months

Collaborators and Investigators

• Sponsor: University of Milan
• Collaborators: Fondazione Humanitas per la Ricerca
• Investigators: Principal Investigator: Guido Torzilli, MD, PhD, University of Milan, Istituto Clinico Humanitas - IRCCS

Publications and helpful links

General Publications

• 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. doi: 10.1097/01.sla.0000145965.86383.89.
• 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. doi: 10.1002/bjs.5321.
• 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. doi: 10.1097/00000658-200012000-00006.
• 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. doi: 10.1016/j.jamcollsurg.2005.04.026.
• 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. doi: 10.1016/j.gassur.2005.08.016.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimate): January 7, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2008
• Last Update Submitted That Met QC Criteria: January 7, 2008
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Liver; hepatectomy; colorectal liver metastases; portal vein embolization; intraoperative ultrasonography
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: MTX-1STAGE; MTX-CRC-1STAGE