Prevention of Bile Leakage After Liver Resection in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorFederal Research Institute of Pediatric Hematology, Oncology and Immunology
About this trial
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.
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. 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.
Participants 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age from birth to 18 years, inclusive.
Presence of a focal liver lesion confirmed by laboratory and imaging findings.
Clinical indication for liver resection.
Involvement of three adjoining liver sections, corresponding to PRETEXT III-based anatomical extent.
Disqualifiers
Tumor invasion of the extrahepatic bile ducts.
Biliary drainage performed before the index liver resection.
Previous liver resection, such that the planned procedure would constitute a repeat liver resection.
Absence of an adequate contrast-enhanced computed tomography examination performed within 28 days before liver resection.
Trial design
Design model
Single group
Treatments tested in this trial
prophylactic extrahepatic biliary drainage during liver resection
Procedure/SurgeryThis 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
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: All participants will undergo prophylactic extrahepatic biliary drainage during liver resection.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the date of liver resection through postoperative day 90Secondary outcomes
1
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
Time frame
During the index liver resection2
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.
Time frame
During the index liver resection3
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.
Time frame
During the index liver resection4
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.
Time frame
: From the date of liver resection through postoperative day 90Sponsors and contacts
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Source ClinicalTrials.gov