Real-time Computer Aided Detection of Barrett's Neoplasia

Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study

In the real-time pilot study, the performance of a recently developed Computer Aided Detection (CADe) system will be investigated in 30 patients during real-time live endoscopic examination. Three expert endoscopists in the field of Barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. In total, 15 patients with a visible neoplastic lesion in their Barrett's esophagus and 15 patients without any visible abnormalities in their Barrett's esophagus will be included in this study. Outcomes: to investigate feasibility of the use of the CADe system in the endoscopy suite, to investigate the performance of the CADe system when used by endoscopists.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Barrett Adenocarcinoma
• Intervention / Treatment: Other: Computer Aided Detection system for Barrett's neoplasia

Detailed Description

Patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known Barrett's esophagus (n = 15).

Patients will be consciously sedated (standard care) before start of the procedure. During the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the Barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the Barrett segment every 2 centimeters. Per 2cm, a video of 10 seconds and 3 overview images are being recorded.

During the imaging protocol, the CADe system presents its prediction on a second screen, next to the main endoscopy monitor. After the imaging protocol, standard clinical care is being resumed.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with Barrett's esophagus, either receiving a surveillance endoscopy according to protocol or referred for endoscopic treatment for proven neoplasia in their Barrett's esophagus

Description

Inclusion Criteria:

• Age > 18 years;
• Patients under surveillance for their diagnosed non-dysplastic Barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma;
• A circumferential Barrett length of at least 2cm

Exclusion Criteria:

• Medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus
• Reflux esophagitis > grade 2 (LA classification)
• Inability to undergo endoscopic treatment and/or biopsies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CADe system; All patients included in the study will undergo the endoscopic procedure according to standard clinical care and the study protocol. The CADe system will run in the back, not interfering with care.	Other: Computer Aided Detection system for Barrett's neoplasia; CADe system running in the back, not directly interfering with patient care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity	To investigate the combined performance between endoscopist and CADe system on a per-patient level.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity	To investigate the performance of the CADe system on new data on a per-patient level.	5 months

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: J.J. Bergman, MD PHD, Amsterdam University Medical Centers, location AMC

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Actual): October 13, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Barrett's Esophagus; Computer Aided Detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 2021.0269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No