Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

NCT06296732 | Recruiting

• 1 other identifier: NCPHOI-2024-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neuroblastoma; Ganglioneuroma; Ganglioneuroblastoma

Keywords

Neuroblastoma; Ganglioneuroma; Ganglioneuroblastoma; Laparoscopic surgery; Minimally-Invasive surgery; IDRF - image-defined risk factors; Risk factors; Difficulty scoring system; Complete resection

Outcome Measures

Primary Outcomes (1)

• Duration of surgery intervention

  Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma

  Intraoperative

Secondary Outcomes (4)

• The influence of surgical risk factors

  Intraoperative and 30 days postoperative

• Cases of conversion from laparoscopic to cavity access

  Intraoperative

• Comparison of surgeon's visual assessment of the tumor resection

  5 days postoperative

• 1-, 3-, 5-years local recurrence-free survival

  up to 5 years

Interventions

Duration of surgery intervention PROCEDURE

Intraoperative- duration from the beginning of the skin incision to skin suture (min)

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal neurogenic tumors in 0-18 years of age

You may qualify if:

• 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:
• and more IDRF + central tumor location and/or tumor extension across the midline;
• and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more;
• and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;
• IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more.
• Age from 0 to 18 years.
• Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).
• Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead
• University Medical Center, Kazakhstan: collaborator

Study Sites (1)

Research Institute of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Neuroblastoma; Ganglioneuroma; Ganglioneuroblastoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Dmitry Akhaladze, MD, Doc

CONTACT

+7 (905) 587-89-92; d.g.akhaladze@gmail.com

Elena Smirnova

CONTACT

+7(985)130-61-03; lena.smirnova@fccho-moscow.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: October 19, 2023
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): November 1, 2031
• Last Updated: May 20, 2024

Record last verified: 2024-02

Locations

RU (1)