Clinical trial · Observational
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ganglioneuroblastoma | Ganglioneuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Ganglioneuroma | Ganglioneuroma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duration of surgery intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Duration of surgery intervention
- timeFrame
- Intraoperative
- description
- Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma
Secondary outcomes (4)
- measure
- The influence of surgical risk factors
- timeFrame
- Intraoperative and 30 days postoperative
- description
- The influence of surgical risk factors (see supplementary material) on the surgery results (see supplementary material) and the course of the postoperative period.
- measure
- Cases of conversion from laparoscopic to cavity access
- timeFrame
- Intraoperative
- measure
- Comparison of surgeon's visual assessment of the tumor resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
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 \-
References
Publications (0)
Data not yet available