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

Hepatic Vein-sparing Hepatectomy for Colorectal Liver Metastases at the Caval Confluence: Validation on Intention-to-treat Analysis of a IOUS-guided Approach

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.

Study Overview

• Status: Completed
• Conditions: Secondary Malignant Neoplasm of Liver
• Intervention / Treatment: Procedure: Hepatic vein-sparing hepatectomy

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patiens undergoing hepatectomy for primary and secondary liver tumors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients having at least one CLM; Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography	Procedure: Hepatic vein-sparing hepatectomy; HV detachment, partial resection and section on the basis of HV-CLM relationship

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the safety of HV-sparing surgery in terms of operative mortality and morbidity	within 30-90 days after surgery

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Study Director: Guido Torzilli, MD,PhD,FACS, Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, Italy; Principal Investigator: Fabio Procopio, MD, Department of Hepatobiliary and General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, Italy

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 7, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplasms; Liver Neoplasms
• Other Study ID Numbers: HV-SparingHx