Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study ID
NCT06296732
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Day - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Duration of surgery intervention — PROCEDURE
    Intraoperative- duration from the beginning of the skin incision to skin suture (min)

Study Details

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.

Key Dates

First listed
Mar 6, 2024
Start date
Oct 19, 2023
Status verified
Feb 2024
Primary completion
Oct 26, 2026
Completion
Nov 1, 2031

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Duration of surgery intervention [ Time Frame: Intraoperative ]

Central Contacts

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