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Trial Title:
Value of Right-sided Hemicolectomy for Chldren With High-risk Neuroendocrine Tumors of the Appendix
NCT ID:
NCT05919758
Condition:
Neoplasms
Appendix Cancer
Conditions: Official terms:
Neuroendocrine Tumors
Appendiceal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
The goal of this observational study is to investigate the beneficial value of
complementary surgery for appendiceal neuro-endocrine tumours in children.
.
Detailed description:
Aim Current guidelines recommend complementary right-sided hemicolectomy for high-risk
(pT2(with risk factors)/pT3) neuro-endocrine tumors (NET) of the appendix (based on adult
studies). In contrast to adults, high-risk NET of the appendix in children seems to be a
relatively benign disease with high disease-free survival (100% versus 70-80% in adults),
but high quality data are lacking. Therefore these recommendations are now being
questioned. We aim to investigate the value of complementary right-sided hemicolectomy
for children with high-risk NET of the appendix. Ultimately leading to the development of
a consensus guideline and solid information for patients/parents.
Plan of investigation In order to generate big data, an international historical cohort
study is planned to compare complementary right-sided hemicolectomy with appendectomy
alone for children with high-risk NET of the appendix. Results will be CONFIDENTIAL used
by an international expert group to formulate treatment recommendations. Subsequently,
these recommendations will be tested in an international Delphi study in order to develop
a consensus guideline on the treatment of pediatric high-risk NET of the appendix.
Expected results The cohort study will generate high quality information on
overall/disease-free survival, recurrence, complications, costs, and hr-QoL.
Recommendations made will be tested in a Delphi study; not only on the beneficial value
of complementary right-sided hemicolectomy, but also on follow-up protocols and
preoperative work-up. Ultimately, an international consensus guideline that redefines
low-risk and high-risk NET of the appendix will be developed, leading to global
de-escalation and uniformity of treatment.
Relevance for childhood cancer Results are relevant for pediatric
oncologists/surgeons/gastro-enterologists across the world, as redefining low-risk and
high-risk patient groups, will lead to de-escalation of treatment. Furthermore, QoL of
child and parents can be improved by reducing exposure to complications after
complementary right-sided hemicolectomy, and by reducing the fear of recurrence by
obtaining high-quality data to accurately inform patients and parents.
Criteria for eligibility:
Study pop:
All patients treated for an appendiceal neuro endocrine tumour before the age of 18
during 1990 and 2020
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
17 Years
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam-Zuidoost
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Ramon R Gorter
Email:
rr.gorter@amsterdamumc.nl
Start date:
May 1, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919758
