Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

NCT06296732 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Duration of surgery intervention

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

Sponsors & Collaborators

  • University Medical Center, Kazakhstan

    collaborator OTHER
  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2026-10-26
Completion
2031-11-01

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06296732 on ClinicalTrials.gov