[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659659":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":38,"studyPopulation":31,"armGroups":39,"interventions":45,"overallOfficials":31,"centralContacts":51,"locations":57,"responsibleParty":74,"collaborators":31,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":31,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":31,"studyType":89,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":60,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"The null hypothesis is that the incidence of bile leakage is equal in the two groups","To compare the incidence of postoperative bile leakage within 90 days after liver resection between the prospective group receiving prophylactic transcystic external biliary drainage and the prespecified historical high-risk control cohort.","From the date of liver resection through postoperative day 90",[14,18,21,24,28],{"measure":15,"description":16,"timeFrame":17},"Unsuccessful prophylactic biliary drainage","Statistical formulation: Proportion of prospectively enrolled participants in whom attempted placement of the transcystic external biliary drainage catheter cannot be successfully completed, with an exact 95% confidence interval","During the index liver resection",{"measure":19,"description":20,"timeFrame":17},"Intraoperative complications","Statistical formulation: Proportion of participants experiencing at least one intraoperative complication and the distribution of complication severity according to the ClassIntra classification. The incidence will be compared between the prospective intervention group and the historical control cohort.",{"measure":22,"description":23,"timeFrame":17},"Severe intraoperative complications","Statistical formulation: Proportion of participants experiencing at least one severe intraoperative complication, defined as ClassIntra grade III or higher, compared between the prospective intervention group and the historical control cohort.",{"measure":25,"description":26,"timeFrame":27},"Postoperative complications","Statistical formulation: Proportion of participants experiencing at least one postoperative complication, classified according to the Clavien-Dindo classification, compared between the prospective intervention group and the historical control cohort.",": From the date of liver resection through postoperative day 90",{"measure":29,"description":30,"timeFrame":12},"Severe postoperative complications","Statistical formulation: Proportion of participants experiencing at least one severe postoperative complication, defined as Clavien-Dindo grade IIIb or higher, compared between the prospective intervention group and the historical control cohort.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"NA","SINGLE_GROUP","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":31},"NONE","Bile leakage is one of the most clinically important complications after liver resection. Reported rates range from approximately 3.6% to 16% in adults and from 14% to 29% in pediatric patients. Postoperative bile leakage may require prolonged drainage, radiological or endoscopic interventions, or repeat surgery and may lead to sepsis, liver failure, prolonged hospitalization, and death.\n\nA previous retrospective analysis of pediatric liver resections performed at the Dmitry Rogachev National Medical Research Center identified a group of patients at increased risk of postoperative bile leakage. The main risk characteristics included tumor adjacency to the hilar plate of the future liver remnant and involvement of three adjoining liver sections. In the historical high-risk cohort, the incidence of postoperative bile leakage was 63%.\n\nThis is a prospective, single-center, open-label, single-group interventional study evaluating prophylactic extrahepatic biliary drainage in children undergoing liver resection. The study will enroll 12 participants aged 0 to 18 years with focal liver lesions requiring surgical resection and a high predicted risk of postoperative bile leakage.\n\nEligibility requires a focal liver lesion confirmed by laboratory and imaging findings, an indication for liver resection, tumor adjacency to the hilar plate of the future liver remnant on contrast-enhanced computed tomography, involvement of three adjoining liver sections corresponding to PRETEXT III anatomical extent, and written informed consent provided by the participant or a legally authorized representative, as applicable.\n\nPatients will not be enrolled if they have tumor invasion of the extrahepatic bile ducts, previous biliary drainage, a history of repeat liver resection, or no contrast-enhanced computed tomography examination performed within 28 days before liver resection.\n\nAfter completion of the liver resection, a straight 18-gauge drainage catheter will be inserted through the cystic duct into the extrahepatic biliary system and used for external biliary drainage. The catheter will be placed as a single prophylactic intraoperative intervention. No drug dose or administration frequency is applicable. The planned duration of drainage is 4 weeks. The catheter will be removed at 4 weeks if no postoperative complications requiring continued biliary drainage have occurred. The feasibility of catheter placement, unsuccessful placement attempts, drainage-related complications, and the actual date of catheter removal will be recorded.\n\nParticipants will be followed for 90 days after liver resection. The primary outcome is the incidence of postoperative bile leakage within 90 days. Bile leakage will be defined according to the International Study Group of Liver Surgery criteria as a bilirubin concentration in abdominal drain fluid at least three times the simultaneously measured serum bilirubin concentration on or after postoperative day 3, or as a biliary collection or biliary peritonitis requiring radiological or surgical intervention.\n\nSecondary outcomes include the incidence and severity of intraoperative complications according to the ClassIntra classification, the incidence of ClassIntra grade III or higher complications, the incidence of postoperative complications within 90 days, the incidence of severe postoperative complications classified as Clavien-Dindo grade IIIb or higher, and the proportion of unsuccessful attempts at extrahepatic biliary drainage.\n\nData collected prospectively will include patient demographics, diagnosis, tumor stage or anatomical extent, previous surgery and chemotherapy, tumor size and location, relationship of the tumor to the hilar plate of the future liver remnant, surgical approach, extent of liver resection, parenchymal transection technique, vascular control, intraoperative blood loss, duration of surgery, postoperative complications, intensive care unit stay, duration of postoperative treatment, length of hospital stay, and timing of abdominal and biliary drain removal.\n\nThe primary and secondary outcomes in the prospective group will be compared with those of a prespecified historical cohort of 41 high-risk patients treated at the same institution. The sample size calculation was based on an expected reduction in the incidence of bile leakage from 63% in the historical high-risk cohort to 13% in the prospective group. With a two-sided significance level of 0.05 and 80% statistical power, 10 prospectively enrolled participants were required. The planned enrollment was increased to 12 participants to account for potentially incomplete data or exclusions.\n\nQuantitative variables will be summarized using medians and interquartile ranges. Distributional assumptions will be assessed before comparative analysis. Categorical variables will be compared using Pearson's chi-square test or Fisher's exact test, as appropriate, and quantitative variables will be compared using the Mann-Whitney U test. A propensity score-based method will be used to improve comparability between the prospective intervention group and the historical control cohort.",[40],{"label":41,"type":42,"description":31,"interventionNames":43},"All participants will undergo prophylactic extrahepatic biliary drainage during liver resection.","EXPERIMENTAL",[44],"Procedure: prophylactic extrahepatic biliary drainage during liver resection",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":31},"PROCEDURE","prophylactic extrahepatic biliary drainage during liver resection","This prospective, single-center, open-label interventional study will enroll 12 children and adolescents aged 0 to 18 years who are undergoing liver resection and are considered to have a high risk of postoperative bile leakage. All participants will undergo prophylactic extrahepatic biliary drainage during liver resection",[41],[52],{"name":53,"role":54,"phone":55,"phoneExt":31,"email":56},"Dmitry G Akhaladze, MD, PHD","CONTACT","+7 (905) 587-89-92","d.g.akhaladze@gmail.com",[58],{"facility":59,"status":60,"city":61,"state":31,"zip":31,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology","RECRUITING","Moscow","Russia","RU",{"type":65,"coordinates":66},"Point",[67,68],37.61781,55.75204,{"lat":68,"lon":67},[71],{"name":72,"role":54,"phone":73,"phoneExt":31,"email":56},"Dmitry G Akhaladze, MD","+7 905 587-89-92",{"type":75,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100659659","prevention-of-bile-leakage-after-liver-resection-in-children-100659659",false,"NCT07867522","Prevention of Bile Leakage After Liver Resection in Children","Biliary Drainage to Prevent Bile Leakage After Liver Resection in Children","Inclusion Criteria:\n\n1. Age from birth to 18 years, inclusive.\n2. Presence of a focal liver lesion confirmed by laboratory and imaging findings.\n3. Clinical indication for liver resection.\n4. Involvement of three adjoining liver sections, corresponding to PRETEXT III-based anatomical extent.\n5. Adjacency of the lesion to the hilar plate or Glissonean structures of the future liver remnant on contrast-enhanced computed tomography performed within 28 days before liver resection. Adjacency is defined as the absence of a visible tissue plane, including direct contact, compression, or radiological evidence of invasion.\n6. Written informed consent provided by the participant's parent or legally authorized representative and assent from the participant, when applicable.\n\nExclusion Criteria:\n\n1. Tumor invasion of the extrahepatic bile ducts.\n2. Biliary drainage performed before the index liver resection.\n3. Previous liver resection, such that the planned procedure would constitute a repeat liver resection.\n4. Absence of an adequate contrast-enhanced computed tomography examination performed within 28 days before liver resection.","ALL","0 Years","18 Years",{"count":87,"type":88},12,"ESTIMATED","INTERVENTIONAL",[33],"Bile leakage is a clinically important complication after liver resection in children and may require prolonged drainage, additional radiological or endoscopic procedures, or repeat surgery. The risk may be particularly high in patients with tumors adjacent to the hilar plate of the future liver remnant and tumors involving three adjoining liver sections.\n\nThis prospective, single-center, open-label interventional study will enroll 12 children and adolescents aged 0 to 18 years who are undergoing liver resection and are considered to have a high risk of postoperative bile leakage. All participants will undergo prophylactic extrahepatic biliary drainage during liver resection. The study hypothesis is that prophylactic biliary drainage will reduce the incidence of bile leakage within 90 days after surgery compared with a prespecified historical cohort of high-risk patients treated at the same center.\n\nParticipants will be followed for 90 days after liver resection. The primary outcome is the incidence of bile leakage during this period. Secondary outcomes include unsuccessful biliary drainage attempts, intraoperative complications, postoperative complications, and serious complications.",[93,94],"Postoperative Bile Leak","Focal Liver Lesions",[96,97,98,99,100,101,102,103,104,105,106,107],"Pediatric liver surgery","liver resection","hepatectomy","posthepatectomy bile leakage","biliary fistula","prophylactic biliary drainage","transcystic biliary drainage","external biliary drainage","focal liver lesions","liver tumors","hilar plate","postoperative complications","2026-10-05",{"date":110,"type":111},"2026-10-09","ACTUAL",{"date":113,"type":111},"2026-02-10",{"date":115,"type":88},"2029-05-02",{"name":5,"class":6},1]