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

Secondary Malignant Neoplasm of Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391207
• Other study ID #: HV-SparingHx
• Status: Completed
• Phase: N/A
• First received: March 7, 2015
• Last updated: March 17, 2015
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 79 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Neoplasms
• Neoplasms
• Neoplasms, Second Primary
• Secondary Malignant Neoplasm of Liver

Intervention

Procedure:
• Hepatic vein-sparing hepatectomy
HV detachment, partial resection and section on the basis of HV-CLM relationship

Locations

Country	Name	City	State
Italy	Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the safety of HV-sparing surgery in terms of operative mortality and morbidity		within 30-90 days after surgery	Yes