Accuracy of endoscopic staging and targeted biopsies for routine gastric intestinal metaplasia and gastric atrophy evaluation study protocol of a prospective, cohort study: the estimate study

• Published in: BMJ open Vol. 9; no. 9; p. e032013
• Main Authors: Nieuwenburg, Stella A V, Waddingham, William W, Graham, David, Rodriguez-Justo, Manuel, Biermann, Katharina, Kuipers, Ernst J, Banks, Matthew, Jansen, Marnix, Spaander, Manon C W
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 18.09.2019; BMJ Publishing Group
• Subjects: Accuracy; Atrophy; Biomarkers; Biopsy - methods; Cohort analysis; Endoscopy; Endoscopy, Gastrointestinal - methods; Female; Gastric cancer; Gastric Mucosa - diagnostic imaging; Gastric Mucosa - pathology; Gastritis, Atrophic - diagnosis; Gastroenterology and Hepatology; Gastrointestinal Neoplasms - pathology; Gastrointestinal Neoplasms - prevention & control; Histopathology; Humans; Image Enhancement - methods; Interest groups; Male; Medical prognosis; Metaplasia - diagnosis; Middle Aged; Multicenter Studies as Topic; Patients; Preventive Health Services - methods; Prospective Studies; Reproducibility of Results; Risk Assessment - methods; Systematic review; United Kingdom > UK; Netherlands; Japan; endoscopy; gastrointestinal tumours; preventive medicine
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2019-032013

IntroductionPatients with chronic atrophic gastritis (CAG) and intestinal metaplasia (IM) are at risk of developing gastric adenocarcinoma. Their diagnosis and management currently rely on histopathological guidance after random endoscopic biopsy sampling (Sydney biopsy strategy). This approach has significant flaws such as under-diagnosis, poor reproducibility and poor correlation between endoscopy and histology. This prospective, international multicentre study aims to establish whether endoscopy-led risk stratification accurately and reproducibly predicts CAG and IM extent and disease stage.Methods and analysisPatients with CAG and/or IM on standard white light endoscopy (WLE) will be prospectively identified and invited to undergo a second endoscopy performed by an expert endoscopist using enhanced endoscopic imaging techniques with virtual chromoendoscopy. Extent of CAG/IM will be endoscopically staged with enhanced imaging and compared with standard WLE. Histopathological risk stratification through targeted biopsies will be compared with endoscopic disease staging and to random biopsy staging on WLE as a reference. At least 234 patients are required to show a 10 % difference in sensitivity and accuracy between enhanced imaging endoscopy-led staging and the current biopsy-led staging protocol of gastric atrophy with a power (beta) of 80 % and a 0.05 probability of a type I error (alpha).Ethics and disseminationThe study was approved by the respective Institutional Review Boards (Netherlands: MEC-2018-078; UK: 19/LO/0089). The findings will be published in peer-reviewed journals and presented at scientific meetings.Trial registration numberNTR7661; Pre-results.