Clinical Research Directory

Augmented Reality Real-Time Guidance for MRI-Guided Interventions

The purpose of this research is to evaluate the safety and feasibility of using a needle guidance system (LUMENA) create by CLEAR GUIDE MEDICAL for needle placement for biopsy or liver tumor ablation procedures.

International Delphi Study to Develop Standardized Quality Criteria and a Rating Tool for Liver CEUS Image Quality Assessment

This study aims to establish international consensus-based quality criteria for contrast-enhanced ultrasound (CEUS) examinations of the liver and to develop a standardized tool for assessing CEUS image quality. CEUS is an established imaging technique used in clinical practice for the characterization and assessment of focal liver lesions and other liver abnormalities. Despite its increasing use, there are currently no universally accepted or validated standards for evaluating the quality and reproducibility of CEUS examinations. The primary objective of this project is therefore to identify robust and clinically relevant quality indicators for liver CEUS examinations through an international Delphi consensus process. The study focuses specifically on CEUS examinations performed in adult patients using the ultrasound contrast agent SonoVue®. The project is divided into two work packages (WP). In Work Package 1 (WP1), the study team will first conduct a structured review of the available literature and discuss potential CEUS quality criteria within the research group. Based on this process, an initial catalogue of quality indicators relating to technical, procedural, and imaging characteristics relevant to liver CEUS examinations will be developed. These proposed criteria will subsequently be evaluated through a multi-round Delphi process involving an international and interdisciplinary panel of experienced CEUS users and experts. A minimum of 20 panellists will participate across all Delphi rounds. Participants will rate their level of agreement with each proposed quality criterion using a 7-point Likert scale and may suggest additional criteria where appropriate. Newly proposed criteria supported by more than 10% of participants will be included in subsequent Delphi rounds. During each round, panellists will receive anonymised feedback summarising the responses of the group and will be invited to re-evaluate the relevance of the proposed criteria. This iterative process will continue for at least three rounds or until predefined consensus criteria are achieved. Consensus will be defined as at least 70% agreement with a rating of 6 or higher on the Likert scale. In Work Package 2 (WP2), the consensus-based quality criteria identified in WP1 will be operationalised into a comprehensive and standardized rating scale for CEUS image quality assessment. Individual criteria will be grouped into broader domains and transformed into practical assessment items and prompts. The resulting rating tool will then be circulated among all Delphi panel members for final review and feedback to ensure clarity, applicability, and international usability. The overall goal of this study is to improve standardization, quality assurance, and reproducibility in liver CEUS examinations. The developed consensus criteria and rating scale may support clinical practice, future research studies, multicentre collaborations, and educational initiatives by enabling more consistent evaluation of CEUS image quality across institutions and countries.

Development of a Predictive Score for the Risk of Infection in the Immediate Post-liver-transplant Period

Liver transplantation (LT) is the only curative treatment option for patients with severe liver disease. Since 2007, the implementation of the MELD score in liver transplant allocation guidelines has led to a change in the profile of transplant recipients, notably with an increase in the proportion of patients receiving transplants for severe liver failure. Thus, in 2023, nearly 40% of liver transplant recipients whose primary indication for LT was cirrhosis had a MELD score greater than 35 (ABM Scientific Report 2023). These patients with severe pre-transplant liver failure often present with associated organ failure (Acute-on-Chronic Liver Failure, ACLF). Infections are the leading cause of death at 1 year post-transplant for patients transplanted with ACLF and are a major concern for all patients, representing one of the leading causes of death at 3 months post-transplant. Another common complication following LT is acute cellular rejection. Although frequent, this complication is reversible with treatment and results in graft loss in fewer than 5% of cases. The expression of the HLA-DR marker by monocytes (mHLA-DR) is correlated with immunoparesis and the risk of secondary infection and mortality in patients admitted to critical care. In a prospective, single-center pilot study of 99 liver transplant recipients, the Hepatology and Gastroenterology service at the Croix Rousse Hospital, Hospices Civils de Lyon, demonstrated that the kinetics of mHLA-DR levels measured immediately after transplantation could predict the risk of early significant infection (\< 1 month) after transplantation and 1-year post-transplant mortality. The early post-transplant kinetics of mHLA-DR expression recovery appeared to be a more relevant predictor of the risk of early post-transplant infection than a single-point-in-time value. The profile of immune recovery kinetics, as well as a pre-LT MELD score \> 30, were associated in multivariate analysis with the risk of developing an infection at 1 month post-LT and with 1-year post-LT survival. PREDITH study team hypothesize that the implementation of mHLA-DR testing immediately post-LT would enable the development of a predictive score for early post-LT infection combining clinical and biological risk factors for post-LT infection and immune monitoring.

AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study

This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.

Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection

To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.

PREDICTT Clinical Trial: Prospective Evaluation Of Pressure-Enabled Delivery And Alterations In CT-Based Tumor-To-Normal Liver Ratio And Tumor Dose Using The Trinav Infusion System

This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.

3D Liver Volumetry

The study aims to improve preoperative evaluation of liver resection volume in patients undergoing major hepatectomies. Accurate prediction of the planned resection and the future liver remnant (FLR) is critical to minimize the risk of postoperative liver failure, which is associated with increased morbidity and mortality. Conventional imaging-based volumetry may have limited accuracy. This study investigates the use of individualized 3D liver models combined to enhance visualization and volumetric analysis of liver anatomy and resection boundaries. Patients are recruited in the liver outpatient clinic and, upon consent, preoperative 3D models are created using Medics 3D. During surgery, the planned resection is guided by the individualized 3D models. Postoperatively, the resected specimen undergoes CT-based volumetry to compare the predicted resection volume from the 3D model with the actual volume. Routine postoperative follow-up is conducted. The study aims to optimize surgical planning, enhance the accuracy of future liver remnant prediction.

The Gastric Bypass Stent System as a Treatment for Hepatic Fibrosis in Obese Patients in European Region

The Gastric Bypass Stent System is intended to be used in weight loss treatment for obesity and holds potential as a non-invasive technique for managing hepatic fibrosis. This pilot, prospective, single-arm, clinical investigation aims to evaluate the safety and performance of the Gastric Bypass Stent System for hepatic fibrosis treatment in Europe. This clinical investigation and the ongoing clinical investigation (Protocol number: BL-RD08-040) will be used to evaluate the safety and performance of the investigational device for the intended use.

Clinical Trial to Evaluate the Effectiveness and Safety of a Remote Automated Ultrasound Diagnostic System for Automated Ultrasound Examinations: a Prospective, Multicenter Study

The purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by Wuhan Cooper Technology Co., Ltd. for automatic ultrasound examination. It aims to answer the main questions: Can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? Will there be medical safety issues during the robot\&#39;s scanning process?

SALT for Patients With Hepatic Cirrhosis

Hepatitis B virus (HBV) infection is a very difficult public health problem in the world. Patients often experience the trilogy of "hepatitis-cirrhosis-liver cancer". Patients with decompensated cirrhosis may develop a variety of complications, such as portal hypertension, hypersplenism, esophageal and gastric variceal bleeding, ascites, spontaneous peritonitis, hepatic encephalopathy, etc. Liver transplantation is the only way to cure hepatitis B cirrhosis. However, the shortage of liver donors still severely limits its development. In 2015, Line and others proposed a new surgical method, namely resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (RAPID). This surgery innovatively combines auxiliary liver transplantation and ALLPS surgery, which can greatly alleviate the problem of liver donor shortage and improve the overall prognosis of the above-mentioned patients. Our center has designed the Sequential Adult Left Lateral Liver Transplantation (SALT) procedure based on the principles of RAPID surgery and the characteristics of patients with cirrhosis. Compared with RAPID surgery, SALT surgery can dynamically monitor and regulate the blood flow of the residual liver and transplanted liver, reducing the risk caused by portal hypertension. This study will evaluate the safety and effectiveness of SALT in the treatment of post-hepatitis B cirrhosis.