PREFER Study
Research type
Research Study
Full title
Endoscopic Management of Patients with T1bN0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry. (Acronym: PREFER study)
IRAS ID
236609
Contact name
Rehan Haidry
Contact email
Sponsor organisation
Amsterdam Medical Centre
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
This is a prospective, multicentre registry study on the safety of endoscopic treatment and follow-up in patients with early cancer of the oesophagus (specifically - submucosal T1bN0M0 oesophageal adenocarcinoma (OAC)). Optimal management of OAC that involves the submucosa (i.e. T1b) is currently uncertain. At present those patients who have undergone endoscopic treatment with resection of early OAC, and are found to have submucosal cancer are offered surgery. This is a major operation that is associated with a significant impact on quality of life and a mortality of 2-4%. However data has shown that the majority of these cases will remain disease free after local endoscopic treatment, regardless of whether they go on to have surgery or not. In other words their surgery may not have been needed. At present there is considerable variability in the management of this type of early cancer throughout the country, this needs to change.
This is an international study led by Amsterdam Medical Centre (AMC) and involves sites in the Netherlands, Belgium, Germany, Sweden, France and the UK. The sites included are all centres with considerable experience in treating this type of early cancer. The study proposes to investigate the safety and efficacy of a conservative treatment algorithm that involves active endoscopic surveillance, rather than surgery. Patients found to have submucosal OAC after endoscopic resection, will be recruited to undergo conservative endoscopic follow up.
The primary outcomes of interest are all cause and disease specific (cancer related) survival (& mortality). Our aim is to show that conservative management of these early cancers is safe and feasible after endoscopic resection, and thereby create a new treatment pathway that could potentially save patients from undergoing major surgery, and lead to significant improvements in quality of life.
REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/0335
Date of REC Opinion
20 May 2020
REC opinion
Further Information Favourable Opinion