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

NCT02391207 | Completed

• 1 other identifier: HV-SparingHx
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Malignant Neoplasm of Liver

Outcome Measures

Primary Outcomes (1)

• the safety of HV-sparing surgery in terms of operative mortality and morbidity

  within 30-90 days after surgery

Study Arms (1)

patients having at least one CLM

Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography

Procedure: Hepatic vein-sparing hepatectomy

Interventions

Hepatic vein-sparing hepatectomy PROCEDURE

HV detachment, partial resection and section on the basis of HV-CLM relationship

patients having at least one CLM

Eligibility Criteria

• Age: 28 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patiens undergoing hepatectomy for primary and secondary liver tumors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, 20089, Italy

Location

Study Officials

• Guido Torzilli, MD,PhD,FACS

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

  STUDY DIRECTOR

• Fabio Procopio, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guido Torzilli, MD, PhD, FACS, Professor of Surgery, Director Department of Hepatobiliary & General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan

Study Record Dates

• First Submitted: March 7, 2015
• First Posted: March 18, 2015
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

IT (1)