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NCT Number: NCT06296732

Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification

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.

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Key information

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

Location status: Recruiting

Location contact

Dmitry m Akhaladze, MD, Doc

CONTACT

[email protected]

+7 (905) 587-89-92,

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.
  • Written voluntary informed consent of the patient and / or his legal representative.

Exclusion criteria

  • 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.
  • 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

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Treatment and study plan

Duration of surgery intervention

Procedure

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

Primary outcomes

  1. Duration of surgery intervention

    Time frame: Intraoperative

    Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma

Secondary outcomes

  1. The influence of surgical risk factors

    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.

  2. Cases of conversion from laparoscopic to cavity access

    Time frame: Intraoperative

  3. Comparison of surgeon's visual assessment of the tumor resection

    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.

  4. 1-, 3-, 5-years local recurrence-free survival

    Time frame: up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Dmitry Akhaladze, MD, Doc

CONTACT

[email protected]

+7 (905) 587-89-92

Elena Smirnova

CONTACT

[email protected]

+7(985)130-61-03

Sponsors and collaborators

Lead sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Other

Collaborators

  • University Medical Center, Kazakhstan

Registry information

Acronym: ANLAP-R

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Mar 6, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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