Alternative to Two-Stage Hepatectomy

Completed

• Conditions: Colorectal Cancer; Liver Metastases
• Interventions: Procedure: One-stage ultrasound guided hepatectomy

• Registration Number: NCT00587756
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2007-05
• Status Verified: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-07
• Last Update Submitted: 2008-01-07
• Last Update Posted: 2008-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	One-stage ultrasound guided hepatectomy	Prospective cohort of consecutive patients who undergo surgery for colorectal cancer liver metastases

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Istituto Clinico Humanitas - Irccs; 🇮🇹 Rozzano - Milano, Italy