Liver Resection Modeling

NCT04023136 | Unknown

• 1 other identifier: APHP 190200
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Benign Liver Tumor; Malignant Tumor Liver; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Estimation of the intraoperative portocaval post-hepatectomy gradient This pressure differential is performed before the parietal closure, after resection. We consider that the simulation is accurate if the difference with the measurement is ≤ 4 mmHg.

  prtocaval gradient (difference between portal pressure and caval pressure assessend during surgery.

Secondary Outcomes (3)

• Prediction of changes in cardiac output, hepatic artery and portal vein after hepatectomy.

  Measures perormed during surgery

• Prediction of changes in hepatic artery flow

  Measures perormed during surgery

• Prediction of changes in portal vein flow

  Measures perormed during surgery

Study Arms (1)

only one arm (resected patients)

OTHER

liver resection group

Procedure: partial hepatectomy by laparotomy on healthy or pathologic parenchyma.

Interventions

partial hepatectomy by laparotomy on healthy or pathologic parenchyma. PROCEDURE

Preoperative flow and MRI + intraoperative measures of flow and pressures

only one arm (resected patients)

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years old informed and consenting.
• Partial hepatectomy by laparotomy (open approach).
• Access to intraoperative measurements of vascular pressures and flow rates.
• Major patients (age≥18 years)
• Hepatic pathology requiring minor or major hepatectomy by laparotomy
• Affiliation to a social security scheme
• Written consent to participate in this research

You may not qualify if:

• Pregnant or breastfeeding women,
• Patient under guardianship or curatorship
• Refusal to participate in the study
• Contraindication to performing MRI.
• Patient already included in an interventional study

Sponsors & Collaborators

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

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Golse Nicolas, M.D

CONTACT

06 71 28 24 03; nicolasgolse@me.com

Vibert Eric, M.D

CONTACT

06 60 64 96 97; eric.vebert.pbr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 17, 2019
• Study Start: July 15, 2019
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-06