[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632301":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":41,"locations":48,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm - White Test","EXPERIMENTAL","Participants allocated to this arm will undergo the White Test after completion of liver parenchymal transection and haemostasis. A cystic duct or cystic duct stump will be cannulated, and the distal extrahepatic bile duct will be temporarily occluded below the cystic duct insertion. SMOFlipid 5% will be administered retrogradely in a volume of 10-20 mL using slow, manual, low-pressure injection. Forceful injection will not be permitted, and injection will be discontinued if abnormal resistance is encountered. Identified leakage sites will be clipped, ligated or sutured, and the test may be repeated until no further leakage is observed. The biliary tree will subsequently be flushed with 20-50 mL of sterile 0.9% sodium chloride solution.",[13],"Procedure: White Test",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm - Standard Gauze Test","ACTIVE_COMPARATOR","Participants allocated to this arm will undergo a standardised white gauze assessment after completion of liver parenchymal transection and haemostasis. Sterile white surgical gauze will be systematically applied to the liver transection surface, and both the gauze and the transection surface will be inspected for visible biliary staining. Identified leakage sites will be clipped, ligated or sutured, and the assessment may be repeated until no further visible leakage is identified. The procedure will be conducted according to a written study-specific standard operating procedure. Alternative active intraoperative bile leak tests will not be permitted as part of the assigned control procedure.",[19],"Procedure: Standard Gauze Test",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","White Test","The White Test is an active intraoperative bile leak assessment performed after completion of liver parenchymal transection and haemostasis. It involves slow, manual, low-pressure retrograde injection of 10-20 mL of SMOFlipid 5% through a cannulated cystic duct or cystic duct stump while the distal extrahepatic bile duct is temporarily occluded. The liver transection surface is inspected for leakage of white emulsion. Identified open bile ducts are clipped, ligated or sutured, and the test may be repeated until no further leakage is observed.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Gauze Test","The standard gauze test is a conventional intraoperative method for bile leak detection. A sterile white surgical gauze is applied to the liver transection surface, and both the gauze and the surgical field are visually inspected for evidence of bile leakage. Detected leaks are managed by ligation or suturing, and the assessment may be repeated as needed according to standard surgical practice.",[15],[32,35,38],{"name":33,"affiliation":5,"role":34},"Piotr Remiszewski, MD, PhD","STUDY_DIRECTOR",{"name":36,"affiliation":5,"role":37},"Paweł Topolewski, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Michał Grąt, MD, PhD,","STUDY_CHAIR",[42,46],{"name":36,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+48 22 599 25 45","pawel.topolewski@wum.edu.pl",{"name":33,"role":43,"phone":44,"phoneExt":26,"email":47},"piotr.remiszewski@wum.edu.pl",[49],{"facility":50,"status":26,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of General, Transplant and Liver Surgery, Medical University of Warsaw","Warsaw","Masovian Voivodeship","02-097","Poland","PL",{"type":57,"coordinates":58},"Point",[59,60],21.01178,52.22977,{"lat":60,"lon":59},[63,65,66,67],{"name":36,"role":43,"phone":64,"phoneExt":26,"email":45},"+48 22 599 2545",{"name":33,"role":43,"phone":44,"phoneExt":26,"email":47},{"name":36,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":33,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":69,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":81,"type":82},270,"ESTIMATED","INTERVENTIONAL",[85],"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.",[88,89,90],"Bile Leak","Liver Resection","Hepatectomy",[92,93,94,95],"liver resection","hepatectomy","bile ducts","white test","NOT_YET_RECRUITING","2026-08-11",{"date":99,"type":100},"2026-08-13","ACTUAL",{"date":102,"type":82},"2026-09-01",{"date":104,"type":82},"2028-03-31",{"name":5,"class":6},1]