Assessing surgical risk factors for laparoscopic surgery in abdominal neuroblastoma

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

This study is trying to see how different factors affect the safety and success of laparoscopic surgery for children with abdominal neuroblastoma.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 1 Day to 18 Years
• Sex: All
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Moscow)
• Trial ID: NCT06296732 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the role of various surgical risk factors in laparoscopic resections of abdominal neuroblastoma and related tumors. It aims to create a novel scoring system based on factors such as tumor size, localization, and previous treatments. Eligible patients, aged 0 to 18 years, will undergo laparoscopic surgery, with assessments of surgical duration, complications, and tumor resection completeness. Follow-up will include monitoring for local recurrence-free survival over five years.

Who should consider this trial

Good fit: Ideal candidates are children aged 0 to 18 years with neurogenic tumors classified as low or moderate risk according to specific criteria.

Not a fit: Patients with high-risk neuroblastoma or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and safety for children undergoing laparoscopic surgery for neuroblastoma.

How similar studies have performed: Other studies have shown promising results with laparoscopic approaches in similar conditions, suggesting potential for success in this novel risk stratification.

Eligibility criteria

Inclusion Criteria:

1. Patients with neurogenic tumors meeting the criteria of groups I-III:

   Group I
   * low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);
   * no IDRF;

   Group II:
   * low or moderate risk group according to pilot difficulty scoring system (less than 5 points);
   * patients with any number of IDRFs and without central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.

   Group III:
   * 2 and more IDRF + central tumor location and/or tumor extension across the midline;
   * 2 and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more;
   * 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;
   * 1 IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more.
2. Age from 0 to 18 years.
3. Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
4. Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.
5. Written voluntary informed consent of the patient and / or his legal representative.

Exclusion Criteria:

1. 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.
2. Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
3. Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
4. Therapy strategy: observation

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Where this trial is running

Moscow

• Research Institute of Pediatric Hematology, Oncology and Immunology — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Dmitry Akhaladze, MD, Doc

Conditions Neuroblastoma; Ganglioneuroma; Ganglioneuroblastoma; Laparoscopic surgery; Minimally-Invasive surgery; IDRF - image-defined risk factors; Risk factors; Difficulty scoring system