Prophylactic extrahepatic biliary drainage to prevent bile leakage after liver resection in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, open-label interventional study enrolling 12 pediatric patients aged 0 to 18 years who are undergoing liver resection and are at high risk for postoperative bile leakage. All participants will receive prophylactic extrahepatic biliary drainage during surgery, and outcomes will be compared to a historical high-risk cohort from the same center. The primary outcome is the incidence of bile leakage within 90 days after surgery. The study aims to determine if the preventive drainage approach lowers leak rates and potentially reduces related complications such as infection or extended hospitalization. Eligibility requires focal liver lesions with specific anatomic risk markers, confirmed need for resection, and consent from guardians with assent when applicable.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Dmitry G Akhaladze, MD, PHD
• Email: d.g.akhaladze@gmail.com
• Phone: +7 (905) 587-89-92

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.