Biliary drainage to prevent bile leaks after liver surgery in children
Tests a drainage procedure during liver surgery in children at high risk of bile leakage.
Plain-language title generated from the registry record
Registry title: Prevention of Bile Leakage After Liver Resection in Children
Key facts
- Where
- Moscow, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 0 and 18 years old?
Source: NCT07867522, who can take part
Where in Russia
- Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and ImmunologyMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Trial code
- NCT07867522
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
Biliary Drainage to Prevent Bile Leakage After Liver Resection in Children
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.
Inclusion: 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; 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; Written informed consent provided by the participant's parent or legally authorized representative and assent from the participant, when applicable.
Exclusion: 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; Tumor invasion of the extrahepatic bile ducts.