Alternative to Two-Stage Hepatectomy

University of Milan19 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Liver Metastases

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinico Humanitas - Irccs

Rozzano - Milano, Italy

Outcomes

Primary Outcomes

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.

Time frame: 30-day and 90-day postoperatively

Secondary Outcomes

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.

Time frame: Minimum Follow-up of 6 months

Data from ClinicalTrials.gov

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