The ESTIMATE Study
Research type
Research Study
Full title
The ESTIMATE Study: Endoscopic Staging and Targeted biopsies for routine gastric Intestinal Metaplasia and gastric ATrophy Evaluation.
IRAS ID
237656
Contact name
Matthew Banks
Contact email
Sponsor organisation
Erasmus Medical Centre
Clinicaltrials.gov Identifier
Z6364106/2018/04/106, Data Protection Registration Number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Gastric cancer survival is poor and recent data suggests the incidence may be increasing. Improving survival for this disease is part of the Government’s Less Survivable Cancers Task Force and in need of urgent research. More accurate and reliable detection of pre-cancerous changes in the stomach, before the development of cancer is essential to changing the outcomes of these patients. Chronic atrophic gastritis (CAG) and gastric intestinal metaplasia (GIM) are both pre-cancerous conditions with an increased risk of gastric cancer. Currently their diagnosis is dependent on tissue samples (biopsies) being taken at random from five areas of the stomach. This strategy has inherent flaws in its accuracy and has poor reliability leading to both under and over diagnosis, with an individual's cancer risk often being inaccurately gauged. In general the greater the spread of these pre-cancerous changes throughout the stomach, the greater the risk of future cancer.
This is a prospective registry study at UCLH NHS Trust and Erasmus Medical Centre Rotterdam. Patients diagnosed with chronic atrophic gastritis and or gastric intestinal metaplasia at endoscopy may be eligible for inclusion into this study. They would then attend for two diagnostic upper endoscopies over the course of the study.
The aim is to define whether "endoscopy-led" diagnosis and staging, can more accurately and reliably assess the extent of CAG and GIM, and therefore more accurately measure that patient's risk of developing cancer. Our study will test a new "endoscopy-led" strategy with enhanced imaging endoscopy and biopsies targeted to the sites of suspected CAG or GIM within the stomach. This protocol will be compared to the current practice of standard "white light" endoscopy with random biopsies. The results from these two methods will then be compared to the results from the tissue biopsy diagnosis (current gold standard) to define the accuracy of each technique.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0089
Date of REC Opinion
3 May 2019
REC opinion
Further Information Favourable Opinion