RecruitingNCT06296732

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification


Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Enrollment

200 participants

Start Date

Oct 19, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.


Eligibility

Min Age: 1 DayMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at which children with abdominal neuroblastoma (a childhood cancer of the nerve tissue) can safely have laparoscopic (keyhole) surgery rather than open surgery, and what factors predict surgical difficulty or risk. **You may be eligible if...** - Your child is between 0–18 years old with a diagnosis of a nerve-related tumor (neuroblastoma) - Pre-surgical imaging has been done within 14 days of planned surgery - The treating team has determined surgery is indicated - The tumor risk level falls within study criteria (low, moderate, or certain higher-risk categories) **You may NOT be eligible if...** - The tumor involves three or more high-risk surgical features plus central location, cross-midline extension, or large size relative to height - Your child has severe other medical conditions that would make surgery more dangerous Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDuration of surgery intervention

Intraoperative- duration from the beginning of the skin incision to skin suture (min)


Locations(1)

Research Institute of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

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NCT06296732


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