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

NCT ID: NCT02391207

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Secondary Malignant Neoplasm of Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients having at least one CLM

Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography

Hepatic vein-sparing hepatectomy

Intervention Type PROCEDURE

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

Interventions

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Hepatic vein-sparing hepatectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

28 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guido Torzilli, MD,PhD,FACS

Role: STUDY_DIRECTOR

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

Fabio Procopio, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Rozzano, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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HV-SparingHx

Identifier Type: -

Identifier Source: org_study_id

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