Prevention of Bile Leakage After Liver Resection in Children

NCT07867522 | Recruiting

• 1 other identifier: 126020916858-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Bile Leak; Focal Liver Lesions

Keywords

Pediatric liver surgery; liver resection; hepatectomy; posthepatectomy bile leakage; biliary fistula; prophylactic biliary drainage; transcystic biliary drainage; external biliary drainage; focal liver lesions; liver tumors; hilar plate; postoperative complications

Outcome Measures

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.

  From the date of liver resection through postoperative day 90

Secondary Outcomes (5)

• Unsuccessful prophylactic biliary drainage

  During the index liver resection

• Intraoperative complications

  During the index liver resection

• Severe intraoperative complications

  During the index liver resection

• Postoperative complications

  : From the date of liver resection through postoperative day 90

• Severe postoperative complications

  From the date of liver resection through postoperative day 90

Study Arms (1)

All participants will undergo prophylactic extrahepatic biliary drainage during liver resection.

EXPERIMENTAL

Procedure: prophylactic extrahepatic biliary drainage during liver resection

Interventions

prophylactic extrahepatic biliary drainage during liver resection PROCEDURE

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

All participants will undergo prophylactic extrahepatic biliary drainage during liver resection.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Biliary Fistula; Carcinoma, Hepatocellular; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Liver Diseases; Pathologic Processes

Central Study Contacts

Dmitry G Akhaladze, MD, PHD

CONTACT

+7 (905) 587-89-92; d.g.akhaladze@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 2, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

RU (1)