Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
Location status: Recruiting
NCT Number: NCT06296732
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.
Interested in participating?
Request Info1 day–18 year
All sexes
Observational
Moscow, Russia
Location status: Recruiting
After signing informed consent and surgical risk factors assessment (see Study Documents), eligible patients received surgical treatment - laparoscopic neuroblastoma resection. Parameters to be assessed are: duration of surgery intervention, intraoperative complications, blood loss volume, cases and volume of blood transfusion, conversion from laparoscopic to cavity access, surgeon's visual assessment completeness of the tumor resection. During 5 postoperative days patients undergo contrast-enhanced abdominal computed tomography (CT) to control completeness of the tumor resection assessment. Postoperative complications during 30 postoperative days to be accessed. In follow up period 1-, 3- and 5 years local recurrence-free survival to be accessed.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group I
Group II:
Group III:
Exclusion criteria
-
Intraoperative- duration from the beginning of the skin incision to skin suture (min)
Time frame: Intraoperative
Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma
Time frame: Intraoperative and 30 days postoperative
The influence of surgical risk factors (see supplementary material) on the surgery results (see supplementary material) and the course of the postoperative period.
Time frame: Intraoperative
Time frame: 5 days postoperative
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.
Time frame: up to 5 years
Contact information is provided by the study sponsor or research team.
Dmitry Akhaladze, MD, Doc
CONTACT
Elena Smirnova
CONTACT
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Other
Acronym: ANLAP-R
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