Clinical trial NCT00587756: Alternative to Two-Stage Hepatectomy
Official title: One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Liver Metastases
Keywords: intraoperative ultrasonography
colorectal liver metastases
hepatectomy
portal vein embolization
Liver
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Fondazione Humanitas per la Ricerca
First posted: 2008-01-07
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients carriers of colorectal cancer liver metastases

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 30-day and 90-day postoperatively
Secondary outcomes:
measure: 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.
timeFrame: Minimum Follow-up of 6 months
Other outcomes:
Locations:
city: Rozzano - Milano
country: Italy
facility: Istituto Clinico Humanitas - Irccs
Study officials:
affiliation: University of Milan, Istituto Clinico Humanitas - IRCCS
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/01.sla.0000145965.86383.89.
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. doi: 10.1016/j.jamcollsurg.2005.04.026.
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. doi: 10.1002/bjs.5321.
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. doi: 10.1016/j.gassur.2005.08.016.