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
Introduction Patients 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...
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BMJ Publishing Group
2019-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e032013.full |
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| author | Manon C W Spaander Matthew Banks Manuel Rodriguez-Justo Marnix Jansen Ernst J Kuipers David Graham Stella A V Nieuwenburg William W Waddingham Katharina Biermann |
| author_facet | Manon C W Spaander Matthew Banks Manuel Rodriguez-Justo Marnix Jansen Ernst J Kuipers David Graham Stella A V Nieuwenburg William W Waddingham Katharina Biermann |
| author_sort | Manon C W Spaander |
| collection | DOAJ |
| description | Introduction Patients 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 analysis Patients 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 dissemination The 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 number NTR7661; Pre-results. |
| format | Article |
| id | doaj-art-66406eea9d8849698f3c32e42c0e3aa3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-66406eea9d8849698f3c32e42c0e3aa32024-11-30T20:45:13ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-032013Accuracy of endoscopic staging and targeted biopsies for routine gastric intestinal metaplasia and gastric atrophy evaluation study protocol of a prospective, cohort study: the estimate studyManon C W Spaander0Matthew Banks1Manuel Rodriguez-Justo2Marnix Jansen3Ernst J Kuipers4David Graham5Stella A V Nieuwenburg6William W Waddingham7Katharina Biermann82 Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The NetherlandsEndoscopy, University College London Hospital, London, UK4 Pathology, University College London Hospitals NHS Foundation Trust, London, UKPathology, University College London Hospital, London, UKGastroenterology & Hepatology, Erasmus MC University Medical Center, Rotterdam, The NetherlandsUniversity College London Hospital, University College London Hospitals NHS Foundation Trust, London, UK3 Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The NetherlandsEndoscopy, University College London Hospital, London, UK6 Department of Pathology, Erasmus Medical Center, Rotterdam, Zuid-Holland, The NetherlandsIntroduction Patients 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 analysis Patients 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 dissemination The 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 number NTR7661; Pre-results.https://bmjopen.bmj.com/content/9/9/e032013.full |
| spellingShingle | Manon C W Spaander Matthew Banks Manuel Rodriguez-Justo Marnix Jansen Ernst J Kuipers David Graham Stella A V Nieuwenburg William W Waddingham Katharina Biermann 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/9/9/e032013.full |
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