Assessing surgical risk factors for laparoscopic surgery in abdominal neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Dmitry Akhaladze, MD, Doc
• Email: d.g.akhaladze@gmail.com
• Phone: +7 (905) 587-89-92

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.