NCT03577067

Brief Summary

Although mortality after liver surgery reduced during the last three decades to less than 2%, post-operative course is still complicated in a range of 20-50% of cases.The identification of one or few factors which could detect the real risk of complicated post-operative outcome, may help anesthesiologist to decide whether admit a patient to ICU or not.The primary aim of this study was to evaluate whether RRI, alone or along with other items, can predict post-operative complication after hepatic resection.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

May 28, 2018

Last Update Submit

July 2, 2018

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

  • renal resistive index (RRI)

    the association between RRI and occurrence of hepatic complications during the first postoperative week.

    up to 7 days after surgery

Study Arms (1)

Patients submitted to liver resection

Patients underwent liver resection for primary and secondary disease

Procedure: Liver resection for primary and secondary disease

Interventions

Liver resection for primary and secondary diseasePROCEDURE

Liver resection in parenchyma-sparing setting for primary and secondary disease

Patients submitted to liver resection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients resectable and affected by primary and secondary liver disease

You may qualify if:

  • Patients resectable and affected by primary and secondary liver disease

You may not qualify if:

  • Subjects affected by kidney disease and/or cirrhosis and pregnant patients were excluded from the trial. Patients who should have needed nephrectomy during the operation would be also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Guido Torzilli, MD, PhD

    Humanitas University

    PRINCIPAL INVESTIGATOR

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

May 28, 2018

First Posted

July 5, 2018

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

July 5, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share