EU-RNEND
Research type
Research Study
Full title
Endoscopic submucosal resection vs. endoscopic full thickness resection for the treatment of rectal neuroendocrine tumours from 10 to 20 mm: a multi-centre randomised trial
IRAS ID
340260
Contact name
Alberto Murino
Contact email
Sponsor organisation
Royal Free NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The objective of this study is to collect data that supports the efficacy of advanced endoscopic methodologies, specifically Endoscopic Submucosal Dissection (ESD) and Endoscopic Full-Thickness Resection (EFTR), in the management of Rectal Neuroendocrine Neoplasms measuring between 10 and 20 millimetres in diameter. At present, both ESD and EFTR are endorsed in clinical practice in the treatment of these diseases, however relying only on retrospective and frequently single-centre observations. Nevertheless, an absence of exhaustive prospective studies, that methodically examine the implementation of these practices, exists.
Recent guidelines from the European Neuroendocrine Tumour Society for the management of Rectal Neuroendocrine Neoplasms confined to the rectum and free of lymph node and systemic metastases endorse EFTR and ESD. Both approaches are firmly established for the treatment of precancerous or malignant lesions of various histological origins (e.g., adenomatous polyps of the rectum, early cancer).
In this study, patients who are eligible for endoscopic treatment after multi-disciplinary team discussion will be randomised to one of the two technique (ESD or EFTR). At the current state of the art, there is no clear indication on whether to use one technique or another.
The main aim of this research is to assess the efficacy of ESD and EFTR based on the achievement of complete histological resection, specifically referred to as R0 – R1 resection.
The secondary objectives of this study will entail: comparing EFTR vs ESD in terms of safety and technical parameters differences (i.e. en-bloc rate; procedure time; intraoperative, peri-procedural and delayed complications); assessing and comparing the endoscopic recurrence rates at 12 months following the procedures; evaluating patient-reported outcome measures (PROM) and quality of life (QoL) in participants who undergo either ESD or EFTR; measuring the length of hospitalization for patients undergoing ESD and EFTR; analyzing the overall costs associated with ESD and EFTR.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0342
Date of REC Opinion
28 Jun 2024
REC opinion
Further Information Favourable Opinion