Hepatic and Systemic Hemodynamic Modeling During Liver Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Centre Hépato-Biliaire - Hôpital Paul Brousse
RECRUITING
Villejuif
Contact Information
Primary
GOLSE Nicolas, M.D
nicolas.golse@aphp.fr
06 71 28 24 03
Backup
VIBERT Eric, M.D
eric.vibert@aphp.fr
06 60 64 96 97
Time Frame
Start Date: 2023-01-03
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 150
Treatments
Experimental: Hepatectomy
Liver resection group
Experimental: Liver Transplantation
Liver Transplantation group
Experimental: Portal vein embolization
Portal vein embolization group
Sponsors
Collaborators: Institut National de Recherche en Informatique et en Automatique
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov