[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bile-leakage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bile-leakage":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100632301","routine-intraoperative-white-test-for-bile-leak-detection-in-liver-resection-100632301",false,"NCT07511907","Routine Intraoperative White Test for Bile Leak Detection in Liver Resection","Routine White Test for Early Detection of Bile Leak in Elective Liver Resection - A Study Protocol for Randomized Controlled Trial (DELiveR Trial).","DELiveR","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Undergoing elective liver surgery (regardless its modality): a) major hepatectomy OR b) minor hepatectomy (anatomic liver resection or non-anatomic liver resection).\n* Possibility of performing the WT: intraoperative, simultaneous cholecystectomy or prior cholecystectomy with identifiable cystic stump allowing bile duct access.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Undergoing intraoperative hepaticojejunostomy.\n* Previous cholecystectomy without accessible cystic stump.\n* Unresectable disease found intraoperatively.\n* Allergy to SMOFlipid 5% components.\n* Pregnancy or lactation.\n* Emergency liver resection.\n* Refusal for participation in trial.","ALL",{"count":19,"type":20},260,"ESTIMATED","INTERVENTIONAL",[23],"NA","Bile leakage (BL) remains one of the most frequent complications following liver resection and is associated with increased postoperative morbidity and mortality, higher reintervention rates, prolonged hospital stay, and increased healthcare costs. Effective intraoperative identification and closure of open bile ducts may reduce the risk of postoperative BL. The White Test, which involves retrograde injection of a lipid emulsion into the biliary tree, enables active detection of bile leaks during surgery; however, its routine use has not been established in randomized clinical trials across all types of liver resection.\n\nThis is a single-center, prospective, randomized, parallel-group, single-blinded superiority trial designed to evaluate the effectiveness of routine intraoperative use of the White Test compared with standard intraoperative bile leak detection using a white gauze test. Adult patients undergoing elective liver resection (major or minor, including both anatomic and non-anatomic resections) who meet eligibility criteria will be enrolled after providing written informed consent.\n\nParticipants will be randomized in a 1:1 ratio to either the intervention group (White Test) or the control group (standard gauze test), using stratified block randomization according to the type of resection (major vs minor). Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Patients will remain blinded to group assignment, while the operating surgeon cannot be blinded due to the nature of the intervention.\n\nIn the intervention group, following completion of liver parenchymal transection and achievement of hemostasis, the cystic duct stump will be identified and cannulated. The distal bile duct will be temporarily occluded, and 10-20 mL of lipid emulsion will be injected retrogradely into the biliary tree. The transection surface will be inspected for leakage of the white emulsion. Identified leaks will be managed by ligation or suturing, and the test may be repeated until no further leakage is observed. In the control group, bile leak detection will be performed by applying sterile white gauze to the transection surface with visual inspection, followed by suturing of identified leaks as needed.\n\nAll patients will have intra-abdominal drainage placed at the resection site. Drain fluid bilirubin concentration will be measured on postoperative day three. Patients will be followed for 30 days after surgery.\n\nThe primary outcome is the incidence of postoperative bile leakage within 30 days, defined according to the International Study Group of Liver Surgery (ISGLS) criteria. Secondary outcomes include severity of bile leakage (ISGLS grades A-C), postoperative morbidity (Clavien-Dindo classification), need for postoperative interventions (endoscopic, radiological, or surgical), intensive care unit (ICU) admission and length of ICU stay, and total hospital length of stay.\n\nThe primary analysis will follow the intention-to-treat principle and will be performed separately within strata defined by resection type (major vs minor). Secondary and subgroup analyses will be considered exploratory. No formal interim analysis is planned; however, patient safety will be continuously monitored throughout the study.\n\nThe results of this trial are expected to clarify the role of routine intraoperative White Test in liver surgery and its potential to reduce postoperative bile leakage and improve clinical outcomes.",[26,27,28,29,30],"Bile Leak","Bile Leakage","Liver Resection","Hepatectomy","Bile Duct Disorder",[32,33,34,35],"liver resection","hepatectomy","bile ducts","white test","NOT_YET_RECRUITING","2026-04-11",{"date":39,"type":40},"2026-04-15","ACTUAL",{"date":42,"type":20},"2026-06-15",{"date":44,"type":20},"2028-10-01",{"name":46,"class":47},"Medical University of Warsaw","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100402702","phase-3-diagnostic-role-of-the-white-test-with-lipidic-solution-in-the-early-intraoperative-identification-of-open-bile-ducts-for-the-prevention-of-bile-leakage-after-liver-resection-bile--trial-100402702","NCT04523701","Diagnostic Role of the \"White Test\" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial)","Diagnostic Role of the \"White Test\" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)","BiLe","Inclusion Criteria:\n\n* Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting\n* Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened\n* Ability of subject to understand character and individual consequences of the clinical Trial\n* Informed consent documented by signature\n\nExclusion Criteria:\n\n* Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump\n* Intraoperative hepatico-jejunostomy\n* Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients\n* Immunosuppression, pregnancy\n* Emergency liver resection because of traumatic liver rupture\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","18 Years",{"count":59,"type":20},210,[61],"PHASE3","Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.",[27],[65,66,67],"Liver resection","SMOFlipid 20%","White Test","RECRUITING","2025-03-11",{"date":71,"type":40},"2025-03-14",{"date":73,"type":40},"2021-03-25",{"date":75,"type":20},"2025-12",{"name":77,"class":47},"Giulia Manzini",5]