Real-time Computer Aided Detection of Barrett's Neoplasia

NCT05628441 | Completed

• 1 other identifier: 2021.0269
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett Esophagus; Barrett Adenocarcinoma

Keywords

Barrett's Esophagus; Computer Aided Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity

  5 months

Study Arms (1)

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

Interventions

Computer Aided Detection system for Barrett's neoplasia OTHER

CADe system running in the back, not directly interfering with patient care

CADe system

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

• Fockens KN, Jukema JB, Jong MR, Boers T, van der Putten JA, Kusters CHJ, Pouw RE, Duits LC, van der Sommen F, de With PH, de Groof AJ, Bergman JJ; BONS-AI consortium. The use of a real-time computer-aided detection system for visible lesions in the Barrett's esophagus during live endoscopic procedures: a pilot study (with video). Gastrointest Endosc. 2024 Sep;100(3):527-531.e3. doi: 10.1016/j.gie.2024.04.011. Epub 2024 Apr 9.

  PMID: 38604297 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• J.J. Bergman, MD PHD

  Amsterdam University Medical Centers, location AMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 28, 2022
• Study Start: May 16, 2022
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)