ENETS-SurvivApp
Research type
Research Study
Full title
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix: An International Multicenter Study (ENETS-SurvivApp)
IRAS ID
281157
Contact name
Hamish Clouston
Contact email
Sponsor organisation
InselGruppe
Clinicaltrials.gov Identifier
NCT0385693, Rgistered with glinicaltrials.gov
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Distant Metastases and Long-Term Survival After Complete Resection of Neuroendocrine Tumors of the Appendix (ENETS-SurvivApp)
Currently it is unclear how neuroendocrine tumors of the appendix with a size of 1-2 cm have to be treated. For tumors smaller than 1 cm and larger than 2 cm it is relatively clear.
For tumors between 1-2 cm there is no clear literature. There are criteria that can be applied to determine the further procedure, but they are based on expert opinion and are purely arbitrary. The current ENETS guidelines provide a right-sided hemicolectomy, if any of these risk factors are present. However, this procedure carries some risks, such as anastomosis insufficiency, which can be potentially life-threatening and would entail subsequent surgery, e.g. stoma. And this without the benefits outweighing the risks, at least not scientifically proven. The aim of the study is to show how often lymph node and/or distant metastases occur, what the risk factors for their formation are, and whether these metastases have clinical relevance. For this purpose, we want to examine patients who underwent surgery between 2005 and 2010 and had a NET of the appendix. The time period was chosen to guarantee a follow-up of 10 years. Since this tumour is rather rare, we need a high number of patients, so we will conduct a Europe-wide multicentre study to accumulate enough patient data and to be able to make a clinically relevant statement, which will lead to new guidelines.REC name
South West - Frenchay Research Ethics Committee
REC reference
21/SW/0152
Date of REC Opinion
22 Oct 2021
REC opinion
Favourable Opinion