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.
low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);
no IDRF;
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.
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.
Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.
Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.
Therapy strategy: observation
Patients with abdominal neurogenic tumors in 0-18 years of age
Cohort
Prospective
Duration of surgery intervention
Procedure/SurgeryIntraoperative- duration from the beginning of the skin incision to skin suture (min)
Duration of surgery intervention
Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma
The influence of surgical risk factors
The influence of surgical risk factors (see supplementary material) on the surgery results (see supplementary material) and the course of the postoperative period.
Cases of conversion from laparoscopic to cavity access
Comparison of surgeon's visual assessment of the tumor resection
Comparison of surgeon's visual assessment of the tumor resection completeness with data from abdominal contrast-enhanced CT, performed in the first 5 days after surgery.
1-, 3-, 5-years local recurrence-free survival
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Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead sponsor
University Medical Center, Kazakhstan
Collaborator
