[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-allograft\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-allograft":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652608","second-generation-laryngeal-mask-airway-vs-endotracheal-intubation-in-adult-liver-transplantation-100652608",false,"NCT07775521","Second-Generation Laryngeal Mask Airway vs Endotracheal Intubation in Adult Liver Transplantation","Safety and Feasibility of Second-Generation Laryngeal Mask Airway Versus Endotracheal Intubation for Anesthesia in Adult Liver Transplantation: A Multicenter, Prospective, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 to 75 years, regardless of sex.\n* Clinical diagnosis of end-stage liver disease, including hepatocellular carcinoma, and scheduled to undergo a first elective allogeneic liver transplantation using the conventional or piggyback technique. Participants with hepatocellular carcinoma must meet the indications for liver transplantation specified in the Chinese Clinical Practice Guidelines for Liver Transplantation for Hepatocellular Carcinoma (2021 Edition). Causes of end-stage liver disease may include, but are not limited to, viral hepatitis-related cirrhosis, alcoholic cirrhosis, and autoimmune liver disease.\n* No severe airway abnormality on preoperative assessment, including severe laryngeal malformation, laryngeal tumor, restricted neck movement, mouth opening less than 3 cm, thyromental distance less than 6.5 cm, or Mallampati class IV.\n* No history or evidence of a high risk of pulmonary aspiration, including gastric retention, intestinal obstruction, severe gastroesophageal reflux disease, or active upper gastrointestinal bleeding.\n* No severe cardiac, pulmonary, or renal organ failure, except for liver disease-related kidney injury, and meeting all of the following criteria:\n* Left ventricular ejection fraction of at least 50% on echocardiography performed within 3 months before surgery, without moderate or severe valvular stenosis or regurgitation, severe ventricular hypertrophy or dilation, regional wall-motion abnormalities, or a large pericardial effusion.\n* No severe and uncorrectable coronary artery stenosis involving the left main coronary artery or multiple major coronary vessels.\n* No acute heart failure or myocardial infarction within 6 months before surgery.\n* No severe or uncontrolled chronic obstructive or restrictive pulmonary disease, with FEV1\u002FFVC greater than 70% and vital capacity greater than 80% of the predicted value.\n* No hepatopulmonary syndrome or severe pulmonary hypertension at rest, with mean pulmonary artery pressure no greater than 35 mmHg.\n* No active pulmonary infection.\n* Estimated glomerular filtration rate of at least 60 mL\u002Fmin\u002F1.73 m2, corresponding to chronic kidney disease stage 1 or 2.\n* Body mass index no greater than 30 kg\u002Fm2.\n* Model for End-Stage Liver Disease score no greater than 30.\n* The participant and family members are adequately informed, willing and able to comply with all study procedures, and provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency liver transplantation or repeat liver transplantation.\n* Contraindication to a laryngeal mask airway or endotracheal intubation, or a known or anticipated difficult airway, including severe airway obstruction, severe cervical spine injury, laryngeal edema, or restricted mouth opening.\n* Previous esophageal or pharyngeal\u002Flaryngeal surgery.\n* High risk of regurgitation or pulmonary aspiration, including severe gastroesophageal reflux disease, markedly increased intra-abdominal pressure due to massive ascites, an inadequately fasted state, or a full stomach.\n* History of two or more upper abdominal operations with extensive intra-abdominal adhesions and an expected operative duration greater than 8 hours.\n* Severe preoperative pulmonary disease meeting criteria for severe respiratory failure, severe chronic obstructive pulmonary disease, or severe restrictive pulmonary disease that is expected to limit tolerance of increased airway pressure.\n* Severe preoperative cardiac disease, including unstable angina or malignant arrhythmia, severe heart failure, or severe pulmonary hypertension.\n* Poorly controlled hypertension, defined as resting blood pressure not adequately controlled to 140\u002F90 mmHg or lower despite systematic pharmacologic treatment.\n* Other severe disease that may limit participation, including poorly controlled diabetes mellitus with glycated hemoglobin greater than 8% after treatment, pulmonary embolism, transient ischemic attack, or stroke.\n* Known allergy to any anesthetic medication planned in the protocol, including propofol, rocuronium, or sufentanil, or to silicone or polyvinyl chloride materials used in the laryngeal mask airway.\n* For participants with hepatocellular carcinoma, severe adverse effects after preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy, such as severe bone marrow suppression or acute deterioration of hepatic or renal function, resulting in inability to tolerate surgery or anesthesia.\n* Another concurrent or previously diagnosed malignancy that has not been cured within the previous 5 years, except for malignancies considered clinically curable, such as cervical carcinoma in situ or basal cell carcinoma of the skin.\n* History of psychiatric illness or cognitive impairment, including epilepsy or dementia, that prevents the participant from understanding or complying with study procedures.\n* Pregnancy or breastfeeding.\n* Participation in another interventional clinical study within 3 months before enrollment.\n* Any other condition that, in the investigator's judgment, may substantially increase study-related risk or interfere with evaluation of study outcomes.","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective, multicenter, randomized controlled trial aims to evaluate the safety and feasibility of second-generation laryngeal mask airway (LMA) management compared with conventional endotracheal intubation (ETT) during general anesthesia in adults undergoing elective liver transplantation. Approximately 100 participants undergoing their first elective liver transplantation will be randomly assigned in a 1:1 ratio to either the LMA group or the ETT group. The study will primarily evaluate a composite endpoint of intraoperative airway-related adverse events, including clinically significant airway leakage, pulmonary aspiration, laryngospasm, bronchospasm, and airway injury. Conversion from LMA to endotracheal intubation, perioperative hemodynamic changes, blood gas measurements, airway placement and removal times, postoperative airway symptoms, pulmonary complications, intensive care unit length of stay, and postoperative hospital length of stay will also be assessed. Participants will be followed during hospitalization and for 3 months after transplantation to evaluate safety, postoperative recovery, rehospitalization, and survival.",[27],"Liver Allograft",[29,30],"ERAS","laryngeal mask airway","RECRUITING","2026-08-16",{"date":34,"type":35},"2026-08-20","ACTUAL",{"date":37,"type":21},"2026-08-03",{"date":39,"type":21},"2027-07-31",{"name":41,"class":42},"Guangzhou Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100649732","phase-3-everolimus-based-calcineurin-inhibitor-free-immunosuppression-one-year-after-liver-transplantation-alternation-100649732","NCT07739914","Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION)","Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION) - a Randomized, Prospective, Multicenter, Open-label, Controlled Phase III Trial","ALTERNATION","Inclusion Criteria:\n\n1. Men\\*\\*, women\\*, inter\u002Fdiverse aged ≥ 18 or \\\u003C80 years\n2. Signed written informed consent from subject\n3. Liver allograft recipients, either deceased or living donor liver transplant\n4. Liver transplantation more than 12 months ago and less than 36 months ago\n5. Recipients of single organ transplant only\n6. LTR on CNI-based maintenance IS\n7. Liver enzymes: ALT \\\u003C 2x ULN and ALP\\\u003C 2 ULN\n8. \\*Women without childbearing potential defined as follows:\n\n   * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or\n   * hysterectomy or uterine agenesis or\n   * ≥ 50 years and in postmenopausal state \\> 1 year or\n   * \\\u003C 50 years and in postmenopausal state \\> 1 year with serum FSH \\> 40 IU\u002Fl and serum estrogen \\\u003C 30 ng\u002Fl or a negative estrogen test, both at screening or\n\n     \\*Women of childbearing potential:\n   * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or\n   * who have sexual relationships with female partners only and\u002For with sterile male partners or\n   * who are sexually active with fertile male partner, have two negative pregnancy tests with a sensitivity of at least 25 mIU\u002Fml during screening (it is recommended that the second test be performed 8-10 days after the first test) and agree to use at least one highly \\*\\*\\* from the time of screening until 8 weeks after completion of treatment (or even 90 days for males if MMF has been taken previously). Preferably, two complementary forms of contraception should be used simultaneously. Pregnancy tests should be repeated if clinically indicated (e.g. after a contraceptive failure has been reported).\n\nExclusion Criteria:\n\n1. Previous CNI-free IS\n2. Acute or chronic rejection within the 36 months prior to screening\n3. Prednisolone intake due to another autoimmune disease for more than 8 weeks\n4. eGFR \\\u003C30ml\u002Fmin and\u002For proteinuria \\>0.5g\u002Fl (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI might be required and proteinuria as a contraindication for mTORI-based therapy)\n5. Need for chronic anti-coagulation that cannot be safely discontinued to perform a liver biopsy\n6. Inability to participate in frequent monitoring of liver function (every 8 weeks) and clinical visits during the trial duration (38 months)\n7. Malignancy or active infection including active, replicative viral hepatitis (chronic hepatitis does not belong to exclusion criteria)\n8. Recurrence of underlying liver disease\n9. Subjects who are pregnant or breastfeeding\n10. Hypersensitivity or intolerance to any of the components of the medications used\n11. Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior enrolment or within five half-lives of the Investigational Medicinal Product (IMP), whichever is longer)\n12. Any medical condition which could compromise participation in the study according to the investigator's assessment.\n13. Accommodation in an institution pursuant to a court or administrative order\n14. Histological exclusion criteria in the baseline screening biopsy:\n\n    1. more than mild portal tract inflammation, presence of interface hepatitis, more than mild lobular inflammation\n    2. presence of biliary inflammation, endothelialitis, portal microvasculitis, central perivenulitis\n    3. advanced fibrosis (≥2 in any scale of LAF score)\n    4. evidence of acute or chronic rejection (T cell-mediated or antibody-mediated, plasma-cell-rich, chronic ductopenic rejection)","80 Years",{"count":54,"type":21},150,[56],"PHASE3","The overall aim of this study is nephroprotection based on a calcineurin inhibitor (CNI)-free therapy beyond year one after orthotopic liver transplantation (OLT) in highly pre-selected patients with low rejection risk.",[27,59,60],"Liver Diseases","Liver Transplantation",[62,60,63,64,65,66,67,68,69],"Liver allograft","Everolimus","Rejection","mammilian target of rapamycin (mTOR) inhibitor","CNI withdrawal","Immunosuppression minimization","Surveillance biopsy","Protocol biopsy","NOT_YET_RECRUITING","2026-07-28",{"date":73,"type":35},"2026-07-31",{"date":75,"type":21},"2026-06-30",{"date":77,"type":21},"2031-06-30",{"name":79,"class":42},"Hannover Medical School",16]