[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"living-donor-liver-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:living-donor-liver-transplantation":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100622405","prediction-models-for-ldlt-outcomes-100622405",false,"NCT07383194","Prediction Models for LDLT Outcomes","A Clinically Applicable Prediction Model for Living Donor Liver Transplantation Outcomes Using the International LDLT Registry","PREDICTLDLT","Inclusion Criteria:\n\n\\- All LDLT donor-recipient pairs registered in the International LDLT Registry from September 1, 2023 to present.\n\nExclusion Criteria:\n\n* Two stage LDLT\n* Dual grafts LDLT","ALL",{"count":19,"type":20},3000,"ESTIMATED","OBSERVATIONAL","Rationale:\n\nLiving donor liver transplantation (LDLT) has emerged as an important option for patients with end-stage liver disease. To facilitate international and meaningful comparisons, our institution participates in the International LDLT Registry. Several models to predict outcomes post-LDLT have been developed to council and justify the major surgery that the living liver donors undergo. However, most proposed models are at high risk of bias and demonstrate suboptimal discriminative ability.\n\nThis study aims to externally validate the most promising prediction models and subsequently, develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nObjective(s):\n\nThe main objective of this study is to develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nThe secondary objective is to externally validate the most promising existing prediction models for LDLT outcomes, using the International LDLT Registry.\n\nStudy type:\n\nThis is an observational, multicenter cohort study using prospectively collected data from the International LDLT Registry. Registry data will be analyzed retrospectively for the purposes of external model validation and prediction model development.\n\nStudy population:\n\nThe study population consists of living liver donors and their corresponding recipients recorded in the International LDLT registry.\n\nMethods:\n\nFor external validation, parameters will be entered in the existing prediction models resulting in the predicted risks. Model discrimination will be measured using the area under the curve (AUC) and by the discrimination slope. The DeLong test will be used to test for difference between the AUC of the different prediction models. Calibration will be evaluated by comparing the observed with the predicted rate of events and graphically represented by calibration plots.\n\nFor the development of a new prediction model, the outcome of interest is early graft failure, defined as graft loss within 90 days after transplantation. A multivariable logistic regression model will be developed to estimate the individual risk of early graft failure. Internal validation will be performed using bootstrapping, and model performance will be assessed in terms of discrimination and calibration. Model performance will also be tested in subgroups.",[24],"Living Donor Liver Transplantation",[26,27,28,29,30],"Liver Transplantation","Living Donor","Graft Survival","Mortality","Prediction Algorithms","NOT_YET_RECRUITING","2026-02-02",{"date":34,"type":35},"2026-02-03","ACTUAL",{"date":37,"type":20},"2026-03-10",{"date":39,"type":20},"2027-07-02",{"name":41,"class":42},"Erasmus Medical Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100562946","the-effect-of-individualised-pain-education-on-chronic-postoperative-pain-development-and-quality-of-life-in-living-liver-donors-100562946","NCT06609772","The Effect of Individualised Pain Education on Chronic Postoperative Pain Development and Quality of Life in Living Liver Donors","Inclusion Criteria:\n\n* No condition that prevents communication\n* Having the ability to read and write\n* No major complications in the early postoperative period\n* No previous abdominal surgery\n* No additional disease that may cause chronic pain\n\nExclusion Criteria:\n\n* Having any condition that prevents communication\n* Lack of reading and writing skills\n* Having a major complication in the early postoperative period\n* Having had abdominal surgery before\n* Having an additional disease that may cause chronic pain",{"count":51,"type":20},120,"INTERVENTIONAL",[54],"NA","Chronic postoperative pain is defined as pain that is a continuation of acute pain or develops after a pain-free period, is localised to the surgical site, affects quality of life, and persists for at least 3 months after surgery when other pain factors are excluded. Chronic postoperative pain, as a major complication of surgery, increases the use of analgesics, restricts activities of daily living, reduces quality of life and creates a serious economic burden. Prolonged pain in the preoperative period and poorly treated postoperative acute pain may trigger the development of chronic pain. Chronic postoperative pain is an important and current problem in living liver transplant donors as in many patient groups.\n\nChronic pain due to severe postoperative acute pain is reported as an expected outcome after open surgical resection in living liver transplant donors. The reason for this is thought to be inadequate perioperative pain management. Inadequate perioperative pain management may lead to sub-optimal pain management, delayed recovery, unexpected readmissions, decreased patient satisfaction, prolonged duration of opioid analgesia with potential for narcotic abuse, and clinical, psychological and socioeconomic consequences that may possibly lead to chronic postoperative pain. Chronic postoperative pain is a common but overlooked complication of surgery that can cause functional limitation, psychological distress and poor quality of life in patients and its management is very important for nurses. An important aim of nursing care is to help liver living donors regain their health and quality of life. Providing management of acute postoperative pain, preventing the development of chronic postoperative pain and improving quality of life in patients undergoing surgical procedures are important issues for nurses. At the same time, chronic postoperative pain management, as a very current issue, requires nurses to plan and implement more effective interventions. With appropriate pain interventions in the preoperative and early postoperative period, the patient should be educated and counselled about self-management strategies, return to normal functionality and the possibility of developing chronic pain after surgery. Adequate perioperative education about the surgery and expected outcomes may alleviate stress, reduce the severity of acute pain and help prevent chronic postoperative pain.\n\nIt is thought that individualised pain education will be effective on chronic postoperative pain development and quality of life of patients. When the literature was reviewed, no study on individualised pain education for liver living donors was found. At the same time, no study was found in the literature in which chronic postoperative pain and quality of life were examined together in liver living donors. The fact that the subject will be investigated for the first time adds originality to the study.\n\nWith this study, the effect of individualised pain education on prevention or reduction of chronic postoperative pain and improvement of quality of life will be determined. Thus, the data obtained can be evaluated holistically and can form the basis for new and large-scale studies in the related field. At the same time, in this prospective study, the rates and characteristics of chronic postoperative pain development in liver living donors at the 3rd month after transplantation will be evaluated. Thus, this study will contribute to the limited literature on this subject.\n\nResearch Hypotheses:\n\nH0a: Individualized pain education applied to living liver donors is not effective on the development of chronic postoperative pain.\n\nH1a: Individualized pain education applied to living liver donors is effective on the development of chronic postoperative pain.\n\nH0b: Individualized pain education applied to living liver donors is not effective on the quality of life of patients.\n\nH1b: Individualized pain education applied to living liver donors is effective on the quality of life of patients.",[57,58,59,60],"Quality of Life","Living-donor Liver Transplantation","Chronic Post Operative Pain","Pain Management",[62,63,64,57],"Living Liver Donors","Chronic Postoperative Pain","Individualised Pain Education","RECRUITING","2024-09-21",{"date":68,"type":35},"2024-09-24",{"date":70,"type":35},"2024-07-19",{"date":72,"type":20},"2025-06",{"name":74,"class":42},"Nazlican Bagci",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":52,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100557535","living-donor-liver-transplantation-for-intrahepatic-cholangiocarcinoma-100557535","NCT06539377","Living Donor Liver Transplantation for Intrahepatic Cholangiocarcinoma","Living Donor Liver Transplantation for Neoadjuvant Treated, Unresectable Intrahepatic Cholangiocarcinoma","LIVINCA","Inclusion Criteria:\n\n* non-resectable intrahepatic cholangiocarcinoma (either for localization \u002F distribution of the carcinoma or for estimated function of the liver in case of liver fibrosis \u002F cirrhosis)\n* biopsy proven grading G1 \u002F G2\n* in case of mixed hepatocellular carcinoma \u002F cholangiocarcinoma, the cholangiocarcinoma also must have a grading of G1 \u002F G2\n* response to chemotherapy in terms of stable or regressive disease (imaging studies, tumor marker CA19-9, any chemotherapy regime allowed, a local-ablative therapy in means of a SIRT is mandatory\n* peritoneal carcinosis \u002F extrahepatic spread ruled out in PET-CT and\u002For MRT\u002FCT and, at latest, during exploration\n* age ≥ 18\n* blood-group compatible living donor available\n* in female patients: negative pregnancy test\n* written informed consent before study enrolment of donor and recipient (all other procedures are clinical routine procedures in the management of these patients)\n\nExclusion Criteria:\n\n* extrahepatic tumor\u002Fmetastases\n* G3 tumors\n* progress under neoadjuvant treatment according to the RECIST-criteria\n* pregnancy or breastfeeding\n* patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons\n* general contraindications for liver transplantation","18 Years",{"count":85,"type":20},6,[54],"This study is supposed to make liver transplantation available for treatment in well selected patients suffering from non-resectable intrahepatic cholangiocarcinoma. Donor organ shortage is currently the main problem for organ transplantation world-wide. Thus, the particular indication \"non-resectable intrahepatic cholangiocarcinoma\" is currently excluded in terms of transplantation. Given those circumstances, transplantation via living donation might be the best option. This procedure does not reduce the deceased donor organ supply because living donation is the primary treatment option in these patients (not subsidiary).",[24,26,89],"Neoadjuvant Therapy",[91,92,93,94],"intrahepatic cholangiocarcinoma","living donor liver transplantation","neoadjuvant therapy","SIRT","2024-08-01",{"date":97,"type":35},"2024-08-06",{"date":99,"type":20},"2024-09-01",{"date":101,"type":20},"2031-10-01",{"name":103,"class":42},"Jena University Hospital"]