NCT07867522Recruiting
Prevention of Bile Leakage After Liver Resection in Children
Biliary Drainage to Prevent Bile Leakage After Liver Resection in Children
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 5 Oct 2026
- Start date
- 10 Feb 2026
- Primary completion date
- 1 May 2029
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- NCT number
- NCT07867522
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 10 Feb 2026 to the primary completion date, 1 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Tumor invasion of the extrahepatic bile ducts.
Who the study is looking for
- 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.
Age in the registry: 0 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.