Study of Hemodynamic Conditions Measured During Hepatectomy

Liver Dysfunction Clinical Trial

— DEBIFOIE  

Official title:

Study of Hemodynamic Conditions Measured During Hepatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371537
• Other study ID #: RIPH3-RNI17/DEBIFOIE
• Secondary ID: 2017-A01754-4920
• Status: Completed
• Start date: October 8, 2017
• Est. completion date: March 19, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 19, 2019
• Est. primary completion date: March 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulatory; Change
• Liver Diseases
• Liver Dysfunction

Intervention

Procedure:
• Liver debit measure
Mesure of liver debit during hepatectomy

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver vessel debit	Mesure of liver debit during hepatectomy	Baseline