PROSPERO Study
Research type
Research Study
Full title
PROspective multicentre Study to identify diagnostic key PERfOrmance indicators in Upper GI Endoscopy(PROSPERO)
IRAS ID
281099
Contact name
Massimiliano di Pietro
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Cancers of the upper gastro-intestinal (GI) tract (oesophagus/gullet, stomach and small bowel) are amongst the deadliest malignancies. The main reason for their high mortality is that they are usually identified late when they are at a non-curable stage. However, a significant volume of research has confirmed that these tumours develop from known recognisable pre-cancerous lesions. This provides an opportunity for clinicians to detect these pre-cancerous areas early and treat them before they progress to cancer. A camera test (endoscopy) is the gold-standard test to detect diseases in these organs. However, there has been limited research to set the standards of the procedure’s performance especially with regards to diagnostic ability of the physician performing the procedure. As such, the aforementioned pre-cancerous lesions are understudied and often go undetected given that it is difficult to find them.
This study aims to understand how often we should be identifying these pre-cancerous lesions on routine endoscopy and investigate to set the standards to measure performance in upper GI endoscopy. We will also assess how often clinicians are correct in detecting pre-cancerous lesions on endoscopy, by comparing the endoscopic findings to the microscope test (histological) results from tissue samples biopsies taken during the procedure. In addition, we will compare expert to less experienced endoscopists in their ability to identify these precancerous lesions. Finally, we will assess whether the time spent to look with the camera inside food pipe stomach and small bowel affects the rate of correct diagnosis.
By evaluating these aspects, we expect to enhance our understanding about key aspects of the diagnosis of these pre-cancerous lesions. In turn we aim to set endoscopy standards to improve their early detection and removal before they progress to cancer with major benefit to patients.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0172
Date of REC Opinion
2 Sep 2021
REC opinion
Further Information Favourable Opinion