[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-leak\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-leak":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100632301","routine-intraoperative-white-test-for-bile-leak-detection-in-liver-resection-100632301",false,"NCT07511907","Routine White Test for Early Detection of Bile Leak in Elective Liver Resection (DELiveR Trial)","Routine White Test for Early Detection of Bile Leak in Elective Liver Resection - A Study Protocol for a Randomized Controlled Trial at a Single High-Volume Hepatobiliary Center in Poland (DELiveR Trial)","DELiveR","Inclusion Criteria:\n\n* Age 18 years or older.\n* Undergoing elective major or minor liver resection, including anatomical or non-anatomical liver resection.\n* Technical eligibility for an attempted White Test, defined as the presence of an identifiable cystic duct or cystic duct stump that can be safely approached for attempted cannulation, as assessed intraoperatively after confirmation of resectability, completion of liver parenchymal transection and achievement of haemostasis.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Intraoperative hepaticojejunostomy.\n* Absence of a cystic duct or cystic duct stump that can be safely approached for attempted cannulation, as determined intraoperatively before randomisation.\n* Unresectable disease identified intraoperatively.\n* Known allergy to components of SMOFlipid 5%.\n* Pregnancy or lactation.\n* Emergency liver resection.","ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"NA","Bile leakage is a clinically important complication following liver resection and is associated with increased postoperative morbidity, need for reintervention and prolonged hospitalisation. The White Test involves retrograde injection of a white lipid emulsion into the biliary tree to facilitate active identification of open bile ducts on the liver transection surface. However, the benefit and safety of its routine use across different types of liver resection remain uncertain.\n\nThe DELiveR Trial is a single-centre, prospective, randomised, parallel-group, participant- and outcome-assessor-blinded superiority trial. A total of 270 adults undergoing elective major or minor liver resection will be randomised in a 1:1 ratio to the White Test or a standardised white gauze assessment.\n\nFinal eligibility will be confirmed intraoperatively after confirmation of resectability, completion of liver parenchymal transection and haemostasis, and confirmation that a cystic duct or cystic duct stump can be safely approached for attempted cannulation. Randomisation will then be performed using a computer-generated sequence with permuted blocks and concealed allocation.\n\nThe White Test will involve slow, manual, low-pressure retrograde injection of 10-20 mL of SMOFlipid 5%, with temporary distal bile duct occlusion. Injection will be discontinued if abnormal resistance is encountered. Identified leakage sites will be clipped, ligated or sutured. The control group will undergo a standardised white gauze assessment according to a study-specific operating procedure.\n\nAll participants will have an intra-abdominal drain placed. Serum and drain-fluid bilirubin concentrations will be measured concurrently on postoperative day 3. Participants will be followed for 30 days.\n\nThe primary outcome is postoperative bile leakage within 30 days according to the International Study Group of Liver Surgery definition. The primary analysis will be conducted in the overall intention-to-treat population using logistic regression. Major versus minor hepatectomy will be evaluated only in exploratory subgroup and interaction analyses.\n\nSecondary outcomes include clinically relevant grade B\u002FC bile leakage, postoperative morbidity, major morbidity, reinterventions, intensive care unit use, hospital length of stay, readmission, mortality and potential intervention-related adverse events. An independent Data and Safety Monitoring Committee will periodically review safety data.",[27,28,29],"Bile Leak","Liver Resection","Hepatectomy",[31,32,33,34],"liver resection","hepatectomy","bile ducts","white test","NOT_YET_RECRUITING","2026-08-11",{"date":38,"type":39},"2026-08-13","ACTUAL",{"date":41,"type":21},"2026-09-01",{"date":43,"type":21},"2028-03-31",{"name":45,"class":46},"Medical University of Warsaw","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100493469","efficacy-of-absolok-clip-system-rfp-2021-01-in-open-liver-resection-100493469","NCT05705557","Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Open Liver Resection","Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection","EBILROK","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Subject has given his informed consent and signed consent;\n* Patients undergoing open liver resection.\n\nExclusion Criteria:\n\n* Surgery made in emergency;\n* Surgery by laparoscopy;\n* Need to perform a bilio-digestive anastomosis;\n* Preoperative jaundice (total bilirubin \\> 3 mg\u002FmL).",{"count":57,"type":21},180,"OBSERVATIONAL","The purpose of this prospective observational study is to evaluate the incidence of Post-Operative Bile Leakage (POBL) using the ABSOLOK™ Clip System during liver parenchymal resection by evaluating the intraoperative and short-term postoperative results. In addition, it will attempt to determine the factors that determine the surgeon's peripheral glissonian pedicle closure method and economic outcomes.",[27],[62,29,63,27,64,65],"Liver resection","Absolok","Laparotomy","Open Liver resection","RECRUITING","2025-08-11",{"date":69,"type":39},"2025-08-14",{"date":71,"type":39},"2023-01-30",{"date":73,"type":21},"2026-03",{"name":75,"class":46},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":47},"100557090","the-effect-of-the-type-of-conduit-duct-anastomosis-technique-on-the-postoperative-course-in-patients-undergoing-liver-transplantation-100557090","NCT06533592","The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation","A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single\u002Fcontinuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.","Inclusion Criteria:\n\n* age over 18\n* elective liver transplantation\n* informed consent to participate in the study\n* recipient bile duct diameter over 3mm\n* donor bile duct diameter over 3mm\n\nExclusion Criteria:\n\n* age below 18\n* pregnancy\n* living donor liver transplantation\n* split-liver or reduced-size liver transplantation\n* liver transplantation other than from brain death donor\n* liver transplantation with hepaticojejunostomy\n* patients undergoing re-transplantation\n* multi-organ transplantation\n* recipient bile duct diameter below 3mm\n* donor bile duct diameter below 3mm","75 Years",{"count":85,"type":21},284,[24],"The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed).\n\nAs part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique.\n\nThe analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival.\n\nAdditionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms.\n\nThe period of observation of the patient after the procedure is planned for 24 months.",[89,90,27,91],"Liver Transplant; Complications","Bile Duct; Stricture, Postoperative","Quality of Life","2024-10-21",{"date":94,"type":39},"2024-10-24",{"date":96,"type":39},"2024-09-28",{"date":98,"type":21},"2028-09-01",{"name":45,"class":46}]