Clinical trial NCT05628441: Real-time Computer Aided Detection of Barrett's Neoplasia
Official title: Real-time Computer Aided Detection of Barrett's Neoplasia: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett Esophagus
Barrett Adenocarcinoma
Keywords: Barrett's Esophagus
Computer Aided Detection
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Combined performance of endoscopist + CADe system in terms of per-patient sensitivity and specificity
timeFrame: 5 months
Secondary outcomes:
measure: Stand-alone performance of CADe system in terms of per-patient sensitivity and specificity
timeFrame: 5 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Amsterdam University Medical Centers, location AMC
name: J.J. Bergman, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: