Evaluating surgery for children with high-risk appendix tumors
The Value of Complementary Right-sided Hemicolectomy for Pediatric Patients With High-risk Neuroendocrine Tumors (NETs) of the Appendix; Towards the Development of an (Inter-) National Consensus Guideline for the Pediatric Population.
This study is testing if a more extensive surgery for children with high-risk appendix tumors is really needed, by comparing results from kids who had that surgery to those who only had their appendix removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam-Zuidoost) |
| Trial ID | NCT05919758 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of complementary right-sided hemicolectomy in children diagnosed with high-risk neuroendocrine tumors of the appendix. Current guidelines suggest this surgical approach based on adult data, but the disease appears to be less aggressive in children, leading to questions about its necessity. By conducting an international historical cohort study, researchers will compare outcomes between children who underwent hemicolectomy and those who had only an appendectomy. The findings will inform the development of consensus guidelines for treating pediatric patients with these tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are children who were treated for appendiceal neuroendocrine tumors before the age of 18 from 1990 to 2020.
Not a fit: Patients with other types of appendiceal malignancies, such as goblet cell carcinoma or adenocarcinoma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored surgical recommendations for children with high-risk neuroendocrine tumors of the appendix, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on pediatric cases, adult studies have shown success with similar surgical approaches, making this an area of ongoing investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients that were treated for an appendiceal NET before the age of 18 years old * Time period: 1990-2020 Exclusion Criteria: * Other appendiceal malignancies/tumours, for example: * goblet cell carcinoma * adenocarcinoma * neuroendocrine carcinoma
Where this trial is running
Amsterdam-Zuidoost
- Amsterdam UMC — Amsterdam-Zuidoost, Netherlands (Recruiting)
Study contacts
- Study coordinator: Ramon R Gorter, MD PhD
- Email: rr.gorter@amsterdamumc.nl
- Phone: 0205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.