Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05339984

Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-27

150

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

Institut National de Recherche en Informatique et en Automatique

Collaborating Sponsor

AI-Summary

What this Trial Is About

" Despite the medical and surgical progress of the last two decades, the selection of candidates for liver surgery remains based on old principles and insufficiently sensitive to fine-tune the gesture to patient-specific characteristics and make almost zero risks of postoperative liver failure (PLF) and death. It is therefore necessary to develop new tools that will make possible to predict the evolution of the postoperative portocaval gradient (difference of pressure between portal vein and vena cava), a well-known major risk factor for PLF. Hemodynamic modeling of the human liver during surgery will represent the purpose of this work in order to help the clinicians in their patient's selection and anticipation of postoperative risk. The aim is to develop and validate an hemodynamics mathematical model to predict the evolution of the portocaval gradient in three surgical situations of increasing complexity: portal modulation by embolization, hepatectomy, and small partial graft liver transplantation. The endpoints will be the estimation of the intraoperative post-procedural portocaval gradient and comparison of the estimated portocaval gradient with that measured at the end of the procedure. This pressure differential is performed before parietal closure, after surgery. "

CONDITIONS

Official Title

Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Liver condition requiring minor or major hepatectomy by open surgery, liver transplantation with small or partial grafts, or portal vein embolization
  • Patients scheduled for major hepatectomy on cirrhosis, or expanded hepatectomy on non-cirrhotic liver if future liver/body weight ratio is less than 0.5
  • Membership in a social security plan
  • Written consent to participate
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients under legal guardianship or curatorship
  • Refusal to participate in the study
  • Medical contraindication to MRI
  • Patients receiving State medical aid

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Trial Site Locations

Total: 1 location

1

Centre Hépato-Biliaire - Hôpital Paul Brousse

Villejuif, Val de Marne, France, 94800

Actively Recruiting

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Research Team

G

GOLSE Nicolas, M.D

CONTACT

V

VIBERT Eric, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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