NCT02404909

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

9.9 years

First QC Date

March 21, 2015

Last Update Submit

March 26, 2015

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

  • to investigate the influence of the liver resection on hemodynamic status in terms of hemodynamic indexes changes

    4 weeks

Study Arms (1)

Patients with liver tumors candidate to hepatectomy

Other: IVC diameters evaluation by intraoperative ultrasound

Interventions

IVC diameters evaluation by intraoperative ultrasoundOTHER

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

Patients with liver tumors candidate to hepatectomy

Eligibility Criteria

Age34 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients underwent liver resection for primary and secondary liver disease

You may qualify if:

  • Patients who underwent hepatectomy for primary and secondary liver tumors

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FACS

Study Record Dates

First Submitted

March 21, 2015

First Posted

April 1, 2015

Study Start

January 1, 2005

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03