MedTrace Logo

Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia

NCT05965921 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 137

Last updated 2025-05-31

No results posted yet for this study

Summary

Barrett's oesophagus is a pre-cancerous condition in which normal cells in the lining of gullet undergo cell changes and this increases the risk of developing adenocarcinoma (a type of cancer) of the gullet. This type of cancer is the 5th most common type of cancer in the UK. To minimise this risk of developing cancer, patients with Barret's oesophagus have regular gastroscopy (a small camera at the tip of the slim tube) every 2-5 years to detect early cancer cell changes. During the procedure, the whole of oesophagus is carefully inspected, and small tissue samples (biopsies) are taken from visible abnormal area within Barrett's oesophagus and sent to the lab to check for cell changes. This is called targeted biopsies. As the endoscopist cannot always tell during gastroscopy where cells are changing, biopsies from each quarter of the gullet (called quadrantic biopsies) are also taken to reduce the risk of pre-cancerous cells being missed. However, this process is time consuming and expensive as numerous biopsies are required.

Recently, there has been a huge development in artificial intelligence (AI). One of these developments is the aid of computer to detect (called computer-aided detection - CAD) the abnormal cell changes within Barrett's during gastroscopy. This system has recently been trained and tested on videos and photos to prove that its performance is as good as expert endoscopists. This system has been already approved to use in the UK. However, this system needs to be tested further and incorporated into real life use to prove that the CAD is useful in detecting cell changes during gastroscopy for targeted biopsies and therefore, the random biopsies can be avoided.

A sample of patients with Barrett's oesophagus will be invited to participate in this study. Participants will have a gastroscopy as part of their usual care for Barrett's oesophagus. Endoscopist will inspect Barrett's oesophagus using AI and will take both targeted biopsies if clinically deemed appropriate along with quadrantic biopsies. Participants will continue to receive usual care and no additional follow up or procedures will be required as part of the study.

Conditions

  • Gastroscopy
  • Barrett's Esophagus

Sponsors & Collaborators

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Brighton and Sussex University Hospitals NHS Trust

    collaborator OTHER

  • University Hospitals Dorset NHS Foundation Trust

    collaborator OTHER_GOV

  • Portsmouth Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Pradeep Bhandari · Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2025-02-27
Completion
2025-03-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965921 on ClinicalTrials.gov