AspECT - A phase III, randomised study of aspirin and esomeprazole chemoprevention in Barrett's metaplasia & oesophagitis.

INTERVENTION: Trade Name: Nexium Pharmaceutical Form: Gastro‐resistant tablet INN or Proposed INN: ESOMEPRAZOLE CAS Number: 119141887 Trade Name: Aspirin Product Name: Aspirin Pharmaceutical Form: Soluble tablet CONDITION: Barrett's Metaplasia PRIMARY OUTCOME: Main Objective: To assess whether intervention with aspirin results in a decreased all causes of mortality or conversion rate from Barrett’s metaplasia to adenocarcinoma or high grade dysplasia.; ; To assess whether high dose PPI therapy decreases the all causes of mortality or conversion rate from Barrett’s Metaplasia to adenocarcinoma or high grade dysplasia.; Primary end point(s): All causes of mortality ; Conversion from Barrett’s metaplasia to adenocarcinoma or high grade dysplasia Secondary Objective: To assess whether intervention with aspirin and/or high dose PPI;; ‐results in decreased cause‐specific mortality.; ‐induces change in expression of molecular markers for BA.; ‐influences the timing and severity of acid reflux into the oesophagus and the change in concentrations of bile acids in the oesophageal aspirates.; Can clinical and molecular risk factors be identified in BM for the development of BA?; To assess the cost effectiveness of the prevention of BA.; Can molecular markers be used to monitor disease and identify high risk groups?; Which new genes are important in the progression of BA?; To investigate host susceptibility genes and environment‐gene interactions.; What are the biological risk factors for cardiac disease and aspirin resistance?; What is aspirin’s role on the development of colorectal adenomas and cancer, intestinal metaplasia of the stomach, and of Barrett’s metaplasia in patients with benign reflux disease. INCLUSION CRITERIA: 1. Aged =18 years 2. Circumferential Barrett’s Metaplasia of at least 1cm in length (=C1M1) or a tongue of Barrett’s metaplasia greater than 2cm in length (=C0M2) (with or without histologically proven intestinal metaplasia in at least one sample from this endoscopy or past history of intestinal metaplasia). 3. Able to give written consent 4. WHO performance status of 0 or 1 i.e. fully active and self‐caring Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range