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OpenTrials
Completed

NCT Number: NCT02391207

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

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.

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Key information

Age range

28 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rozzano, Milan, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hepatic vein-sparing hepatectomy

Procedure

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

Primary outcomes

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

    Time frame: within 30-90 days after surgery

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Mar 18, 2015
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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