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RECRUITING
NCT05339984
NA

Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

" 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. "

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-01-03

Completion Date

2026-06-01

Last Updated

2025-06-27

Healthy Volunteers

No

Interventions

PROCEDURE

Partial hepatectomy (open approach)

preoperative flow MRI + intraoperative measures of flow and pressures + pre/intra/post-procedural ultrasonographic flowmetry

PROCEDURE

liver transplantation

preoperative flow MRI + intraoperative measures of flow and pressures + pre/intra/post-procedural ultrasonographic flowmetry

PROCEDURE

Portal vein embolization

preoperative flow MRI + intraoperative measures of flow and pressures + pre/intra/post-procedural ultrasonographic flowmetry

Locations (1)

Centre Hépato-Biliaire - Hôpital Paul Brousse

Villejuif, Val de Marne, France