Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	1 Day - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

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. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06296732
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Russian Federation
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma, Ganglioneuroma, Ganglioneuroblastoma

Additional Details

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.

Contact a Trial Team

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International Sites

Moscow, Russian Federation

Status

Recruiting

Address

Research Institute of Pediatric Hematology, Oncology and Immunology

Moscow, ,

Site Contact

Dmitry m Akhaladze, MD, Doc

[email protected]

+7 (905) 587-89-92,

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