NCT00587756

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
Last Updated

January 8, 2008

Status Verified

December 1, 2007

Enrollment Period

5.7 years

First QC Date

January 3, 2008

Last Update Submit

January 7, 2008

Conditions

Colorectal CancerLiver Metastases

Keywords

intraoperative ultrasonographycolorectal liver metastaseshepatectomyportal vein embolizationLiver

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

1

Prospective cohort of consecutive patients who undergo surgery for colorectal cancer liver metastases

Procedure: One-stage ultrasound guided hepatectomy

Interventions

One-stage ultrasound guided hepatectomyPROCEDURE

Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients carriers of colorectal cancer liver metastases

You may qualify if:

  • Patients presenting with resectable colorectal cancer liver metastases (CLM)
  • 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).

You may not qualify if:

  • Patients with 3 or less resectable CLM
  • Patients with 4 or more resectable CLM but nor bilobar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas - Irccs

Rozzano - Milano, 20089, Italy

Location

Related Publications (5)

  • 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.

    PMID: 11088072BACKGROUND

  • 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.

    PMID: 15570209BACKGROUND

  • 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.

    PMID: 16183489BACKGROUND

  • 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.

    PMID: 16953487BACKGROUND

  • 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.

    PMID: 16269386BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Guido Torzilli, MD, PhD

    University of Milan, Istituto Clinico Humanitas - IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 7, 2008

Study Start

September 1, 2001

Primary Completion

May 1, 2007

Study Completion

December 1, 2007

Last Updated

January 8, 2008

Record last verified: 2007-12

Locations

IT(1)