Hepatic Vein-sparing Hepatectomy for Colorectal Liver Met... | NCT02391207

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

NCT02391207

Sponsor

University of Milan

Status

Completed

Last Update Posted

Mar 18, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Secondary Malignant Neoplasm of Liver

Interventions

Hepatic vein-sparing hepatectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 7, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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 MilanPrincipal Investigator

Lead Sponsor

University of MilanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients having at least one CLM		Hepatic vein-sparing hepatectomy guided by intraoperative ultrasonography	Procedure: Hepatic vein-sparing hepatectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatic vein-sparing hepatectomy	Procedure	HV detachment, partial resection and section on the basis of HV-CLM relationship	patients having at least one CLM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the safety of HV-sparing surgery in terms of operative mortality and morbidity		within 30-90 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Patiens undergoing hepatectomy for primary and secondary liver tumors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan		Rozzano	Milan	20089	Italy