DEBIFOIE: Study of Hemodynamic Conditions Measured During Hepatectomy

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT03371537

Collaborator

(none)

Enrollment

Location

17.3

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction Circulatory; Change	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 Design

Study Type:

Observational

Actual Enrollment :

9 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of Hemodynamic Conditions Measured During Hepatectomy

Actual Study Start Date :

Oct 8, 2017

Actual Primary Completion Date :

Mar 19, 2019

Actual Study Completion Date :

Mar 19, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Liver vessel debit [Baseline]
Mesure of liver debit during hepatectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS	Tours		France	37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT03371537

Other Study ID Numbers:

RIPH3-RNI17/DEBIFOIE
2017-A01754-49
2017-61

First Posted:

Dec 13, 2017

Last Update Posted:

Mar 18, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Mar 18, 2021