Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence

Completed

• Conditions: Secondary Malignant Neoplasm of Liver
• Interventions: Procedure: Hepatic vein-sparing hepatectomy

• Registration Number: NCT02391207
• Lead Sponsor: University of Milan

Brief Summary

Major hepatectomies are generally selected for tumors involving the hepatic vein (HV) at the caval confluence (CC). As alternative, HV reconstruction has been proposed. The present study aimed to evaluate the feasibility and safety of a HV-sparing policy guided by intraoperative ultrasonography (IOUS) in a cohort of patients having at least one colorectal liver metastasis (CLM) in contact with a HV at CC. HV section can be avoided in the large majority of cases thanking to CLMs detachment or to HV partial resection or reconstruction: this policy seems feasible, safe, reduces the need of major hepatectomies, and oncologically provides an adequate local control.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Study First Submitted: 2015-03-07
• Study First Submitted QC: 2015-03-17
• Last Update Submitted: 2015-03-17
• Study First Posted: 2015-03-18
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• diagnosis of at least one CLM in contact with HV at caval confluence and HV patency at preoperative imaging
• at least 6 months of follow-up after surgery

Exclusion Criteria

• suspected or ascertained thrombosis or full tumoral involvement of HV at preoperative imaging
• portal pedicle infiltration and/or thrombosis
• unresectability at laparotomy for any extra-hepatic or intrahepatic reason not related to tumor-vessel relations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients having at least one CLM	Hepatic vein-sparing hepatectomy	Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography

Primary Outcome Measures

Name	Time	Method
the safety of HV-sparing surgery in terms of operative mortality and morbidity	within 30-90 days after surgery

Trial Locations

Locations (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan; 🇮🇹 Rozzano, Milan, Italy