Complicated Outcome Prediction After Liver Resection

Complicated Outcome Prediction After Liver Resection: the Role of Renal Resistive Index

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.

Study Overview

• Status: Completed
• Conditions: Liver Neoplasms
• Intervention / Treatment: Procedure: Liver resection for primary and secondary disease

• Study Type: Observational
• Enrollment (Actual): 183

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients resectable and affected by primary and secondary liver disease

Description

Inclusion Criteria:

Patients resectable and affected by primary and secondary liver disease

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients submitted to liver resection; Patients underwent liver resection for primary and secondary disease	Procedure: Liver resection for primary and secondary disease; Liver resection in parenchyma-sparing setting for primary and secondary disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal resistive index (RRI)	the association between RRI and occurrence of hepatic complications during the first postoperative week.	up to 7 days after surgery

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Guido Torzilli, MD, PhD, Humanitas University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: CE Humanitas 100/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No