[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-tumor-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-tumor-surgery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100586108","phase-2-sh-lps-system-in-preoperative-planning-for-liver-resection-100586108",false,"NCT06911086","SH-LPS System in Preoperative Planning for Liver Resection","SH-LPS System in Preoperative Planning for Liver Resection: a Randomized Controlled Trial","Inclusion Criteria:\n\n* 18-80 years old;\n* Patients with a resectable tumor in the liver;\n* Eastern Cooperative Oncology Group Performance status score: 0;\n* Child-Pugh classification: A;\n* The Laboratory test results meet the following criteria and patients can tolerate surgery: Haemoglobin≥90g\u002FL, Neutrophil count≥1.5×10⁹\u002FL, Platelet count≥100×10⁹\u002FL, Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN）, alkaline phosphatase≤2.5 ULN, Serum albumin≥30g\u002FL, serum creatinine\\\u003C1.5 ULN, International normalized ratios（INR）≤2 or rothrombin time（PT）exceed ULN≤6s, Creatinine clearance≥60 mL\u002Fmin.\n\nExclusion Criteria:\n\n* Patients with extra-hepatic metastasis;\n* Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation in 28 days prior to the surgery;\n* Clinically significant bleeding or bleeding tendencies within 3 months prior to enrollment or on thrombolytic or anticoagulant therapy;\n* Severe lung disease (eg, acute lung disease, pulmonary fibrosis that affects lung function, interstitial lung disease), uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol\u002FL);\n* There are other unsuitable candidates for clinical trials, such as mental illness or alcohol dependence.","ALL","18 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Effective preoperative planning and real-time intraoperative guidance are crucial for performing accurate liver resections. To address this need, the researchers have designed advanced 3D-printed liver models using a self-healing elastomer, created through the copolymerization of 4-acryloylmorpholine (ACMO) and methoxy poly(ethylene glycol) acrylate (mPEGA). These models demonstrate outstanding healing properties, swiftly restoring their structure within minutes at room temperature, and quickly recovering after incisions.\n\nIn previous studies, Professor Yuhua Zhang, the project applicant, collaborated with a team from Zhejiang University to develop a 3D-printed liver model that is self-healing and reusable for repeated cutting. They preliminarily explored the feasibility of applying this model for preoperative planning and surgical training for liver surgeries. The results were published in Nature Communications (Lu et al., Nat Commun. Dec 19;14(1):8447). Building on this, the applicant intends to establish a personalized liver surgery planning system (Personalized Liver Surgery Planning System Based on High-Fidelity 3D Printed Self-Healing Liver Models, SH-LPS), which will assess, through a randomized controlled trial, the value of SH-LPS in improving liver surgery efficiency and safety.",[28,29,30],"Liver Tumor; Surgery","3D Printing","Preoperative Planning","NOT_YET_RECRUITING","2025-04-02",{"date":34,"type":35},"2025-04-04","ACTUAL",{"date":37,"type":21},"2025-04-15",{"date":39,"type":21},"2026-06-01",{"name":41,"class":42},"Zhejiang Cancer Hospital","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100585642","stroke-volume-variation-versus-central-venous-pressure-guidance-for-reducing-perioperative-blood-loss-during-open-liver-resection-100585642","NCT06905015","Stroke Volume Variation Versus Central Venous Pressure Guidance for Reducing Perioperative Blood Loss During Open Liver Resection","Comparison the Effectiveness of Stroke Volume Variation Versus Central Venous Pressure Guidance for Reducing Perioperative Blood Loss During Open Liver Resection: A Prospective, Double-Blinded, Noninferiority, Randomized Controlled Study","Inclusion Criteria:\n\n* All genders, age 18 to 70 years old\n* American Society of Anesthesiologists (ASA) physical status classification of I-III\n* The patients who scheduled in elective open liver resection and diagnosed Hepatocellular Carcinoma, Cholangiocarcinoma, Liver metastasis, and Benign malignant tumor.\n\nExclusion Criteria:\n\n* Pregnancy\n* Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, active coronary artery disease within 6 months prior surgery)\n* History of significant cerebrovascular disease (Patients with clinically significant stroke\u002FCVA within 6 months prior surgery, severe carotid stenosis)\n* Renal dysfunction (GFR \\\u003C 60 ml\u002Fmin\u002F1.73 m²)\n* Abnormal coagulation parameters (INR \\>1.5 not on warfarin and\u002For platelet count \\\u003C100,000)\n* Preoperative autologous blood donation\n* Tumor size \\> 10 cm.\n* Previous liver resection\n\nWithdrawal criteria:\n\n* Unresectable tumor\n* Persistent intraoperative hypotension that cannot be corrected with vasopressors.\n* Cardiac arrest during operation\n* Low central venous pressure (CVP \\\u003C 5 mmHg) or high stroke volume variation (SVV \\>13%) cannot be achieved before and during liver parenchymal transection.","20 Years","70 Years",{"count":53,"type":21},74,[55],"NA","Liver resection is a major surgery that can be associated with significant intraoperative blood loss and blood transfusion. Among high-volume centers, median intraoperative blood loss ranges between 300-800 ml. Excessive blood loss is a strong independent predictor of worsened postoperative outcomes, increasing morbidity and mortality rates by 20%-35%. Additionally, perioperative allogeneic blood transfusions are associated with deleterious outcomes, including tumor recurrence and increased rates of complications and death.\n\nThe liver is a highly vascular organ with minimal vascular resistance, receiving up to 25% of cardiac output and pooling 20% of the splanchnic blood. Hepatic veins are a common source of venous hemorrhage. The pressure in the hepatic veins is directly correlated with the pressure in the vena cava and reducing cardiac preload results in decreased hepatic vein congestion. Therefore, low central venous pressure anesthesia (typically below 5 mmHg) can reduce the pressure gradient for retrograde venous bleeding, facilitate the outflow of blood from hepatic veins, and decrease blood volume and pressure in the liver. This anesthetic method is the standard technique to minimize blood loss during liver resection.\n\nCentral venous pressure was the static parameter used to indicate the right ventricular end-diastolic volume index (RVEDI) and was believed to be correlated with volume status. Despite this, central venous pressure did not reliably predict preload responsiveness due to the curvilinear shape of the ventricular pressure-volume curve, which indicates a poor relationship between ventricular filling pressure and volume. Additionally, the placement of a central venous catheter could lead to serious complications such as arterial cannulation, pneumothorax, and infection.\n\nArterial waveform analysis is dynamic hemodynamic monitoring based on the interaction between the heart and lungs in patients with mechanical ventilation. Stroke volume variation (SVV) is one aspect of arterial pressure waveform analysis and is a less invasive alternative technique for guiding preload status and fluid management in patients undergoing major abdominal surgery.\n\nIn liver resection, several anesthetic methods are used to achieve low central venous pressure (CVP \\\u003C 5 mmHg) during the liver parenchymal dissection phase. These methods include intraoperative volume restriction, administration of venodilators or vasodilators, the use of forced diuresis with furosemide, and the implementation of hypovolemic phlebotomy. As mentioned, central venous pressure is a static hemodynamic monitoring parameter and poorly correlates with volume status. Recently, stroke volume variation has been recognized as a good parameter to predict volume status and fluid responsiveness in patients undergoing liver resection. However, no previous publications have studied the efficacy of stroke volume variation monitoring compared with central venous pressure monitoring to reduce perioperative blood loss during open liver resection.\n\nThe study aimed to compare the efficacy of maintaining high stroke volume variation versus low central venous pressure in reducing perioperative blood loss during the liver transection phase in open liver resection.",[28,58,59,60,61],"Primary Liver Tumor, Metastatic Liver","Primary Liver Cancer","Liver Resection","Benign Liver Tumor",[63,64,65,66],"Stroke volume variation","central venous pressure","open liver resection","blood loss","RECRUITING","2025-03-25",{"date":70,"type":35},"2025-04-01",{"date":72,"type":35},"2024-11-25",{"date":74,"type":21},"2028-06-30",{"name":76,"class":42},"Warangkana Lapisatepun",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":77},"100546675","phase-4-the-preoperative-administration-of-icg-improves-tumor-detection-in-patients-undergoing-minimally-invasive-hepatic-resection-guided-by-conventional-intraoperative-ultrasound-100546675","NCT06398028","The Preoperative Administration of ICG Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.","The Preoperative Administration of ICG (Indocyanine Green) Improves Tumor Detection in Patients Undergoing Minimally Invasive Hepatic Resection Guided by Conventional Intraoperative Ultrasound.","Inclusion Criteria\n\n* Patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital's multidisciplinary liver tumor board (MDTB).\n* Contrast enhanced MRI within 6 weeks prior to liver surgery\n* ≥18 years old\n* Absence of exclusion criteria and able to provide consent for data collection and analysis\n\nExclusion Criteria\n\n* Emergency surgery\n* Patients in which ICG is contraindicated: previous history of iodine hypersensitivity, patients with renal failure (GFR \\\u003C60 mL\u002Fmin\u002F1.73 m2), uremia, clinical hyperthyroidism, autonomic thyroid adenomas, or focal and diffuse autonomic abnormalities of the thyroid gland.\n* Previous liver surgery.",{"count":86,"type":21},173,[88],"PHASE4","Summary:\n\nPreoperative administration of indocyanine green (ICG) improves the detection of liver tumors in patients undergoing minimally invasive liver resection guided by conventional intraoperative ultrasound. The primary objectives of this study are to evaluate the efficacy of ICG fluorescence uptake in combination with intraoperative ultrasonography and preoperative magnetic resonance imaging for detecting liver tumors. Additionally, a machine-learning algorithm will be developed to enhance liver tumor detection using ICG through photographic analysis. Secondary objectives include investigating the distribution of ICG in liver tissue and its correlation with hepatic fibrosis and steatosis, as well as describing patterns of ICG uptake and their relationship with liver tumors. The study also aims to analyze various clinical outcomes such as the 30-day comprehensive complication index, operation time, conversion to open surgery rate, length of hospital stay, liver tumor recurrence, readmission rate, complications, and 90-day mortality. This research seeks to advance tumor detection methods and improve patient outcomes in minimally invasive liver resection procedures.",[28],"2024-04-30",{"date":93,"type":35},"2024-05-03",{"date":95,"type":35},"2023-08-19",{"date":97,"type":21},"2028-03-19",{"name":99,"class":42},"Hospital Universitari Vall d'Hebron Research Institute"]