Inferior Vena Cava Index in Patients Undergoing Liver Res... | NCT02404909

Studies
Inferior Vena Cava Index in Patients Undergoing Liver Resection

NCT02404909

Sponsor

University of Milan

Status

Completed

Last Update Posted

Apr 1, 2015Estimated

Enrollment

91Actual

Phase

Not provided

Conditions

Liver Neoplasms

Interventions

IVC diameters evaluation by intraoperative ultrasound

Countries

Not provided

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 2005

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Mar 21, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Apr 1, 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 26, 2015

Last Update Posted Date

Apr 1, 2015Estimated

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

The aim of this study was to evaluate whether IVC index measured intraoperatively was affected by fluid administration and could add any helpful information about the hemodynamics during hepatic resection. In addition, the investigators evaluated whether IVC index was somehow correlated with the risk of postoperative complication.

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

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with liver tumors candidate to hepatectomy			Other: IVC diameters evaluation by intraoperative ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IVC diameters evaluation by intraoperative ultrasound	Other	Out of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent hepatectomy for primary and secondary liver tumors

Exclusion Criteria:

Patients with tumoral thrombosis or full tumoral involvement/compression of IVC were excluded. Patients unresectable at laparotomy for any extra-hepatic or intrahepatic reason and patients previously submitted to hepatectomy were not included

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

34 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients underwent liver resection for primary and secondary liver disease

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided