Actively Recruiting
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2024-05-20
200
Participants Needed
1
Research Sites
419 weeks
Total Duration
On this page
Sponsors
F
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead Sponsor
U
University Medical Center, Kazakhstan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with neurogenic tumors meeting criteria of groups I-III risk groups based on surgical scoring and IDRF presence
- Age from 0 to 18 years
- Preoperative abdominal contrast-enhanced CT performed no later than 14 days before planned surgery
- Surgical indication confirmed by multidisciplinary expert board
- Written voluntary informed consent from patient or legal representative
You will not qualify if you...
- Having 3 or more IDRFs with central tumor location and/or tumor extension across the midline and/or tumor volume to patient height ratio of 28 or more
- Severe additional medical conditions increasing anesthesia or surgical risk as judged by the research physician or team
- Tumor volume unsuitable for minimally-invasive surgery as decided by multidisciplinary experts
- Treatment strategy of observation without surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
Actively Recruiting
Research Team
D
Dmitry Akhaladze, MD, Doc
CONTACT
E
Elena Smirnova
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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