Clinical trial NCT06296732: Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Official title: Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
Collaborators: name: University Medical Center, Kazakhstan
First posted: 2024-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with abdominal neurogenic tumors in 0-18 years of age

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.

Detailed description: 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.

Eligibility 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

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Primary outcomes:
measure: Duration of surgery intervention
timeFrame: Intraoperative
Secondary outcomes:
measure: The influence of surgical risk factors
timeFrame: Intraoperative and 30 days postoperative
measure: Cases of conversion from laparoscopic to cavity access
timeFrame: Intraoperative
measure: Comparison of surgeon's visual assessment of the tumor resection
timeFrame: 5 days postoperative
measure: 1-, 3-, 5-years local recurrence-free survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Institute of Pediatric Hematology, Oncology and Immunology
Study officials:
References: