Study of Hemodynamic Conditions Measured During Hepatectomy (DEBIFOIE)

Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation.

The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.

It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function.

The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.

Study Overview

• Status: Completed
• Conditions: Liver Dysfunction; Circulatory; Change
• Intervention / Treatment: Procedure: Liver debit measure

Detailed Description

Measurements of flow rates in the portal vein and the hepatic artery by different transit times are available thanks to the Medistim VeriQTM system that the investigators already use routinely in the context of liver transplantation when performing hepatectomies.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient undergoing laparotomy for liver resection

Description

Inclusion Criteria:

• patient 18 years or more
• Patient undergoing laparotomy for liver resection

Exclusion Criteria:

• Patient under tutorship or curatorship
• Pregnant or lactating woman
• Difficulties in understanding French
• Patient operated by laparoscopy
• Patient having objected to the processing of his data

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatectomy; Patient undergoing laparotomy for liver resection. The aim is to measure the flow rates in the portal vein and the hepatic artery.	Procedure: Liver debit measure; Mesure of liver debit during hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver vessel debit	Mesure of liver debit during hepatectomy	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Ephrem SALAME, MD-PhD, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2017
• Primary Completion (Actual): March 19, 2019
• Study Completion (Actual): March 19, 2019

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: RIPH3-RNI17/DEBIFOIE; 2017-61 (CPP); 2017-A01754-49 (Other Identifier: IdRCB)

Drug and device information, study documents

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