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Clinical Trials in France / NCT05339984
Recruiting Not applicable

Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

NCT05339984 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-01-03
Last updated
2025-06-27

Condition(s) studied

Liver DiseasesLiver Transplantation

Investigational drug(s) / intervention(s)

Partial hepatectomy (open approach)liver transplantationPortal vein embolization

Partial hepatectomy (open approach): preoperative flow MRI + intraoperative measures of flow and pressures + pre/intra/post-procedural ultrasonographic flowmetry

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

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

Study 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. "

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Liver pathology requiring minor or major hepatectomy by laparotomy, or transplantation with small livers (graft weight/patient weight ratio \< 0. 01) or partial livers (living donor recipient or auxiliary grafts) or portal embolization (all patients scheduled for major hepatectomy on cirrhosis, or expanded hepatectomy on non-cirrhotic liver if and only if the ratio of future remaining liver/body weight is \<0.5. * Membership in a social security plan * Written consent to participate in this research * Adult patients (age ≥18 years) Exclusion Criteria: * Pregnant or breastfeeding women * Patient under guardianship or curatorship * Refusal to participate in the study * Contraindication to performing of MRI. * Patient Under State medical aid

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Hépato-Biliaire - Hôpital Paul Brousse Villejuif Val de Marne Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05339984 on ClinicalTrials.gov ↗ ← All trials in France