The Impact of Artificial Intelligence (AI) on the Quality of Upper Gastrointestinal (GI) Endoscopy

NCT05845463 | Unknown DMC

• 1 other identifier: V0.1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Oesophageal and gastric cancer are two of the six less survivable cancers, responsible for half of cancer deaths and a quarter of cancer cases. Six cancer charities have called for focused efforts to improve the poor outcomes for these cancers that have changed little in recent years (lesssurvivablecancers.org.uk). Improving endoscopy standards to minimise missed cancer cases will be an important contribution to improving oesophageal and gastric cancer outcomes. Endoscopy, flexible telescopic examination of the oesophagus, stomach and duodenum, is the method of choice for diagnosing upper gastrointestinal (UGI) cancer and its main purpose is usually to exclude cancer as the cause of peoples' symptoms. Over 1,000,000 endoscopies are undertaken each year in the UK but the test is not perfect and sometimes cancer or an abnormality that will turn into cancer is not found. When this happens, the cancer is known as a post-endoscopy upper gastrointestinal cancer (PEUGIC) or a 'missed' cancer. This is unfortunately a relatively common occurrence and 9% of people with UGI cancer in the UK (approximately 1400 per year) had an endoscopy that did not find their cancer in the three years before diagnosis. All people who undergo endoscopy will benefit from this research. Reducing the future number of cancers that are missed at endoscopy in England will be a direct benefit but preventing missed cancers will also help to improve the general quality of endoscopy. The rate of missing cancer at colonoscopy (post-colonoscopy colorectal cancer) has fallen from 9% in 2005 to 6.5% in 2013, unlike the PEUGIC rate that has increased between 2009 and 2018. Research has shown that endoscopists with longer procedure times and those who take more than four pictures during endoscopy have a higher abnormality detection rate for early cancer. In an attempt to help endoscopists, a novel AI called Cerebro has been developed as an endoscopy quality control tool. Cerebro gives the endoscopist real time feedback during an endoscopy, and aids them in the four following areas (Endovision AI 2022)

1. 1.Ensures inspection completeness prompting the endoscopist on which areas have been missed.
2. 2.Calculates the time spent at each landmark ensuring at least a 7-minute examination time.
3. 3.Provides automatic photodocumentation which allows for better reporting
4. 4.Prompts the endoscopist when further insufflation or washing is needed to improve views Variation in endoscopy quality in the UK will contribute to variations in missed cancer frequency and efforts to improve endoscopy quality, including using AI to standardise endoscopy quality, will hopefully reduce the frequency of PEUGIC in future and improve upper GI cancer outcomes. However, in order for AI use in endoscopy to be established its value in improving the quality of views needs studying.

Conditions

Endoscopy, Digestive System

Keywords

Endoscopy; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Number of sites successfully inspected during endoscopy (0-28)

  Number of sites successfully inspected during endoscopy (0-28)

  During time of endoscopy

Secondary Outcomes (2)

• Overall procedure time

  During time of endoscopy

• Individual site inspection time

  During time of endoscopy

Study Arms (2)

Endoscopists with AI feedback

EXPERIMENTAL

This will be the group of endoscopists who will have AI feedback during the endoscopy

Device: Cerebro endoscopy quality control tool

Endoscopists without AI feedback

ACTIVE COMPARATOR

This will be the group of endoscopists without AI feedback during the endoscopy to assess their baseline site detection rate. Both arms will cross over to see if AI improves endoscopy quality and if its removal decreases quality.

Device: Cerebro endoscopy quality control tool

Interventions

Cerebro endoscopy quality control tool DEVICE

The AI provides feedback via a separate screen to the endoscopists to inform them which part of the upper GI tract have been adequately visualised.

Endoscopists with AI feedback; Endoscopists without AI feedback

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age or above who are scheduled for outpatient diagnostic UGI endoscopy will be invited to part take in the study.

You may not qualify if:

• The following subjects will be excluded from the study:
• Inpatient/ emergency OGD referrals
• Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion),
• Previous gastro-duodenal surgery
• Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease)

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

Study Sites (1)

Sandwell General Hospital

Birmingham, West Midlands, B71 4HJ, United Kingdom

Location

Study Officials

• Nigel Trudgill, MbChB

  Sandwell General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amar Srinivasa, BMBS

CONTACT

07795084514; amarsrinivasa@nhs.net

Nigel Trudgill, MbChB

CONTACT

nigel.trugill@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible as endoscopists randomised into 2 groups one with AI assistance and one without assistance
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Model Details: The research team propose to carry out a randomised crossover trial to assess the impact of AI on the quality of upper GI endoscopy

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)