Modeling liver blood flow during surgery
Hepatic and Systemic Hemodynamic Modeling During Liver Surgery
NA · Assistance Publique - Hôpitaux de Paris · NCT05339984
This study is testing a new way to predict blood flow changes during liver surgeries to help doctors choose the right patients and reduce the risk of liver failure after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Villejuif, Val de Marne) |
| Trial ID | NCT05339984 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a mathematical model to predict the evolution of the portocaval gradient during liver surgeries, including partial hepatectomy and liver transplantation. By utilizing hemodynamic modeling, the research seeks to enhance the selection of candidates for liver surgery and anticipate the risk of postoperative liver failure. The approach focuses on three surgical scenarios of increasing complexity, addressing the challenges posed by chronic liver diseases and the need for precise surgical evaluations. The ultimate goal is to improve patient outcomes by minimizing the risks associated with liver surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with liver diseases requiring minor or major hepatectomy or liver transplantation.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of postoperative liver failure and improve survival rates for patients undergoing liver surgery.
How similar studies have performed: While the approach of hemodynamic modeling in liver surgery is innovative, similar studies have shown promise in improving surgical outcomes through advanced predictive tools.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Villejuif, Val de Marne
- Centre Hépato-Biliaire - Hôpital Paul Brousse — Villejuif, Val de Marne, France (RECRUITING)
Study contacts
- Study coordinator: GOLSE Nicolas, M.D
- Email: nicolas.golse@aphp.fr
- Phone: 06 71 28 24 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Diseases, Liver Transplantation, Benign Liver Tumor, Primary Liver Tumor, Secondary liver tumor, Cirrhosis, Portal hypertension, small-for-size syndrome