NCT07867522 Prevention of Bile Leakage After Liver Resection in Children

Eligibility & Interventions

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This trial targets 12 participants in total. It began in 2026-02-10 with a primary completion date of 2029-05-01.

Brief Summary

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

Inclusion Criteria: 1. Age from birth to 18 years, inclusive. 2. Presence of a focal liver lesion confirmed by laboratory and imaging findings. 3. Clinical indication for liver resection. 4. Involvement of three adjoining liver sections, corresponding to PRETEXT III-based anatomical extent. 5. 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. 6. Written informed consent provided by the participant's parent or legally authorized representative and assent from the participant, when applicable. Exclusion Criteria: 1. Tumor invasion of the extrahepatic bile ducts. 2. Biliary drainage performed before the index liver resection. 3. Previous liver resection, such that the planned procedure would constitute a repeat liver resection. 4. Absence of an adequate contrast-enhanced computed tomography examination performed within 28 days before liver resection.

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