Diagnostic Performance Indicators in Upper GI Endoscopy:PROSPERO Study

Summary

Cancers of the upper gastro-intestinal tract, including esophagus (gullet), stomach and small bowel, are amongst the deadliest malignancies. The main reason for their high mortality rate is that they are usually diagnosed late when curative treatments are no longer effective. However, these types of cancer generally arise from well-described pre-cancerous diseases, such as Barrett's esophagus and gastric intestinal metaplasia. This provides an opportunity for clinicians to detect these pre-cancerous conditions early and offer adequate cure or clinical monitoring before they progress to cancer. A camera test (gastroscopy) is the gold-standard test to detect pre-cancerous diseases in these organs.

There has been limited research to set the standards for performance of a gastroscopy, especially with regards to diagnosis of pre-cancerous conditions, which require knowledge and skills by the physician performing the test (endoscopist). Therefore, the hypothesis behind this study is that the aforementioned pre-cancerous diseases are understudied and often go undetected. This study aims to understand how often endoscopists should diagnose these pre-cancerous diseases on routine gastroscopy and help define the standards to measure performance. The investigators will assess the following rates: i. how often endoscopists diagnose these pre-cancerous lesions during endoscopy; ii. How often these conditions are diagnosed on biopsies taken according to a standardized protocol; iii. How often these condition should have been diagnosed by the endoscopists based on the review of pictures by expert endoscopists. The investigators will also compare the rates of correct diagnosis by endoscopists with different levels of experience and based on the times spent to complete the diagnostic test.

Investigating these aspects will enhance the understanding of the medical community with regards to the diagnosis of these pre-cancerous lesions and set endoscopy standards to improve their early detection and treatment before they progress to cancer. This will translate to improved cancer prevention and benefit for patients.

Conditions

• Esophageal Cancer
• Gastric Cancer
• Barrett Esophagus
• Gastric Atrophy
• Gastric Intestinal Metaplasia
• Duodenal Adenoma
• Esophageal Dysplasia
• Duodenum Cancer
• Gastric Polyp
• Barretts Esophagus With Dysplasia

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

• Massimiliano Di Pietro, MD · MRC Cancer Unit,Hutchison/MRC Research Centre

• Ines Modolell, MD · Cambridge University Hospitals

• Andreas V Hadjinicolaou · Cambridge University Hospitals

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2022-06-01

Completion

2022-09-15