Actively Recruiting
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2024-05-20
200
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
F
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead Sponsor
U
University Medical Center, Kazakhstan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the role and impact of various surgical risk factors in laparoscopic surgery for abdominal neuroblastoma, including benign ganglioneuroma and high-risk neuroblastoma. The study aims to develop a new risk scoring system to better understand which factors influence surgical outcomes, such as tumor size, image-defined risk factors (IDRF), tumor location, and previous treatments. This observational phase III study builds on existing experience with minimally invasive surgery in this condition. Eligible patients undergo laparoscopic neuroblastoma resection after surgical risk factors are assessed. During surgery, researchers monitor factors like operation duration, blood loss, complications, and if conversion to open surgery is needed. Post-surgery, patients have contrast-enhanced abdominal CT scans for five days to check completeness of tumor removal, with follow-up assessments for complications over 30 days and local recurrence-free survival evaluated at 1, 3, and 5 years. Participants are involved in preoperative imaging and surgical treatment, followed by detailed postoperative monitoring including imaging and complication tracking. Researchers assess surgical duration, risk factors’ influence, conversion rates to open surgery, surgeon’s tumor resection assessment, and long-term local recurrence. The total follow-up period extends up to five years to monitor outcomes and tumor recurrence.
CONDITIONS
Brief Title
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 0 to 18 years
- Diagnosis of neurogenic tumors classified in groups I-III with specified surgical risk levels
- Group I: low or moderate risk and no image-defined risk factors (IDRF)
- Group II: low or moderate risk with any number of IDRFs but no central tumor location or tumor extension across midline and/or tumor volume to height ratio of 28 or more
- Group III: defined combinations of IDRFs, tumor location, tumor extension, tumor volume to height ratio, and other risk factors as per pilot difficulty scoring
- Preoperative abdominal contrast-enhanced CT scan performed within 14 days before planned surgery
- Surgery indication confirmed by a multidisciplinary expert board
- Written informed consent from patient or legal representative
You will not qualify if you...
- Presence of three or more IDRFs combined with central tumor location, tumor extension across the midline, or tumor volume to height ratio of 28 or more
- Severe additional health conditions increasing surgical or anesthesia risks as decided by physician or expert board
- Tumor volume too large to allow minimally invasive surgery as determined by expert board
- Treatment strategy involves observation without surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 days plus surgery day
Participants undergo laparoscopic neuroblastoma resection. Surgical risk factors such as duration of surgery, intraoperative complications, blood loss, and conversion to open surgery are assessed. Participants have daily contrast-enhanced abdominal CT scans for 5 days after surgery to evaluate tumor resection completeness and monitor post-operative complications.
1 surgery visit and 5 daily post-operative visits (in-person)
Duration - 30 days
Postoperative complications are monitored for 30 days after surgery.
Approximately 6 post-operative visits
Duration - Up to 5 years
Participants are monitored for local recurrence-free survival at 1, 3, and 5 years after surgery.
3 follow-up visits at 1, 3, and 5 years
Trial Site Locations
Total: 1 location
1
Research Institute of Pediatric Hematology, Oncology and Immunology
Moscow, Russia
Actively Recruiting
Research Team
D
Dmitry Akhaladze, MD, Doc
E
Elena Smirnova
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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