Alternative to Two-Stage Hepatectomy

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587756
• Other study ID #: MTX-1STAGE
• Secondary ID: MTX-CRC-1STAGE
• Status: Completed
• Phase: N/A
• First received: January 3, 2008
• Last updated: January 7, 2008
• Start date: September 2001
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas - Irccs	Rozzano - Milano

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	Fondazione Humanitas per la Ricerca

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No