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Laparoscopic versus open surgery for pediatric liver tumor: a prospective, open-label, multicenter, non-randomized controlled phase III study

Laparoscopic versus open surgery for pediatric liver tumor: a prospective, open-label, multicenter, non-randomized controlled phase III study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093933
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-31
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric liver tumor

Interventions

Laparoscopy group:Laparoscopic liver resection(LLR)
Open sugery group :Open liver resection(OLR)

Sponsors

The Second Affiliated Hospital, Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0.5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Age: 6 months ~ 18 years old, any gender; 2) Patients with resectable liver tumors, either primary or secondary; 3) PRE/POSTTEXT stage I/II; 4) Estimated Functional liver volume of at least 30%; 5) Informed consent signed by the child and/or his/her parent or legal guardian;

Exclusion criteria

Exclusion criteria: 1) a previous abdominal surgery, with the exception of the following: hepatic puncture biopsy, multiple hepatic resections, ablations and minor surgeries such as hernias. 2) Pediatric ASA classification = III; 3) Combination of other malignant tumors; 4) Expected inability to adhere to follow-up; 5) Patients deemed unsuitable by the investigator;

Design outcomes

Primary

MeasureTime frame
Event free survival rate;

Secondary

MeasureTime frame
Perioperative complications;Hospital stay after surgery;Overall survival rate; Pediatric Quality of Life Inventory Generic Core Scales, and Cancer Module;

Countries

China

Contacts

Public ContactYa Gao

The Second Affiliated Hospital of Medical School, Xi'an Jiaotong University

ygao@xjtu.edu.cn+86 139 9113 1816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026