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

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02391207
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 71
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Malignant Neoplasm of Liver	Procedure: Hepatic vein-sparing hepatectomy

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. the safety of HV-sparing surgery in terms of operative mortality and morbidity [within 30-90 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan	Rozzano	Milan	Italy	20089

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Guido Torzilli, Guido Torzilli, MD, PhD, FACS, Professor of Surgery, Director Department of Hepatobiliary & General Surgery, University of Milan, Humanitas Research Hospital, Rozzano, Milan, University of Milan
• ClinicalTrials.gov Identifier: NCT02391207
• Other Study ID Numbers: HV-SparingHx
• First Posted: Mar 18, 2015
• Last Update Posted: Mar 18, 2015
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Neoplasms; Liver Neoplasms

Study Results

No Results Posted as of Mar 18, 2015