Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

NCT05339984 | Recruiting

• 1 other identifier: APHP220133
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. "

Conditions

Liver Diseases; Liver Transplantation

Keywords

Benign Liver Tumor; Primary Liver Tumor; Secondary liver tumor; Cirrhosis; Portal hypertension; small-for-size syndrome

Outcome Measures

Primary Outcomes (1)

• Estimation of the intraoperative portocaval post-procedural gradient.

  The pressure differential is performed before the parietal closure, after resection. The simulation is accurate if the difference with the measurement is ≤ 3 mmHg.

  measures performed during surgery.

Secondary Outcomes (3)

• Prediction of the evolution of portal pressure after surgery

  measures performed during surgery.

• Prediction of the evolution of cardiac outpout after surgery

  measures performed during surgery.

• Prediction of the evolution of hepatic artery and portal vein flows after surgery

  measures performed during surgery.

Study Arms (3)

Hepatectomy

EXPERIMENTAL

Liver resection group

Procedure: Partial hepatectomy (open approach)

Liver Transplantation

EXPERIMENTAL

Liver Transplantation group

Procedure: liver transplantation

Portal vein embolization

EXPERIMENTAL

Portal vein embolization group

Procedure: Portal vein embolization

Interventions

Partial hepatectomy (open approach) PROCEDURE

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

Hepatectomy

liver transplantation PROCEDURE

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

Liver Transplantation

Portal vein embolization PROCEDURE

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

Portal vein embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator

Study Sites (1)

Centre Hépato-Biliaire - Hôpital Paul Brousse

Villejuif, Val de Marne, 94800, France

RECRUITING

MeSH Terms

Conditions

Liver Diseases; Fibrosis; Hypertension, Portal

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Central Study Contacts

GOLSE Nicolas, M.D

CONTACT

06 71 28 24 03; nicolas.golse@aphp.fr

VIBERT Eric, M.D

CONTACT

06 60 64 96 97; eric.vibert@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 21, 2022
• Study Start: January 3, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)