Alternative to Two-Stage Hepatectomy

NCT ID: NCT00587756

Last Updated: 2008-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-09-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

One-stage ultrasound guided hepatectomy

Intervention Type PROCEDURE

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

Interventions

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One-stage ultrasound guided hepatectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Humanitas per la Ricerca

OTHER

Sponsor Role collaborator

University of Milan

OTHER

Sponsor Role lead

Responsible Party

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University of Milan, Istituto Clinico Humanitas - IRCCS

Principal Investigators

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Guido Torzilli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milan, Istituto Clinico Humanitas - IRCCS

Locations

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Istituto Clinico Humanitas - Irccs

Rozzano - Milano, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 11088072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15570209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16183489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16953487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16269386 (View on PubMed)

Other Identifiers

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MTX-CRC-1STAGE

Identifier Type: -

Identifier Source: secondary_id

MTX-1STAGE

Identifier Type: -

Identifier Source: org_study_id

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