Artificial-intelligence-based QUAntification of Size measuremeNts of Adenoma in Routine Endoscopy

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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NCT-Nummer:
NCT06040710

Studienbeginn:
Januar 2024

Letztes Update:
01.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Wuerzburg University Hospital

Collaborator:
-

Kontakt

Alexander Hann, Professor
Kontakt:
Phone: +49 931 201-45918
E-Mail: hann_a@ukw.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
Deutschland» Google-Maps

Studien-Informationen

Detailed Description:

Objective:

The primary aim of this study is to conduct a superiority analysis between POSEIDON and

endoscopist optical estimation, focusing on the errors of polyp size measurement. Secondary

objectives encompass subgroup analyses concerning varying polyp sizes and histology,

potential impact on follow-up protocols based on polyp sizes, and determination of the

percentage of cases where obtaining measurements with POSEIDON proves unfeasible.

Study Design:

Single center, endoscopist blinded study. Considering the results of the preliminary study, a

total of 42 pairs of measurements suffices to extrapolate statistical significance for a

power of 90% and a significance level of 0.05. Taking dropout rates, average number of polyps

per patient, polyp detection rate, the number of patients expected to be enrolled for the

study is 156. For obtaining the gold standard measurement, images from the examination

recording where the tip of a snare is placed next to the polyp are extracted. The snare tip

and polyp are manually segmented and their largest diameter in pixels is manually calculated.

The diameter of the snare-tip will be measured after the examination to account for

production based variations. Based on this, the gold standard polyp size is calculated.

AI setup and limitations:

The version of the polyp detection system, EndoMind, is an updated version of the one

published in (PMID: 35543874). Notably, the POSEIDON method has undergone dual refinements

from its first published version (PMID: 37080235). Firstly, the AI model for water-jet tip

detection has been further trained using images from colonoscopy videos, leading to

performance improvements. Secondly, the pixel-to-millimeter conversion methodology has been

optimized to align with the specifications of the endoscopes employed in the trial.

To obtain a polyp size estimation, initially the polyp is detected by means of a bounding box

through the EndoMind system. Then, once water-jet is sprayed next to the polyp, POSEIDON

detects the tip of the water-jet, where it touches the mucosa. The coordinates of the tip in

the endoscopic image are correlated to the distance of the endoscope to the mucosa. With the

above, the largest diameter of the bounding box is converted from pixels to millimeters,

resulting in the size estimation.

For measurement acquisition, the system is initiated at the beginning of the examination and

deactivated at its conclusion, facilitated by a dedicated button press. Concerning

expert-system interaction, the CADe system's identifications consistently appear on an

auxiliary screen within the endoscopist's workspace. On this screen, precise visualization of

the impact point between the water-jet beam and the mucosa follows water-jet detection.

Subsequently, the endoscopist receives visual affirmation of a successful calculation of

polyp size estimation, derived from the bounding box on the screen. The endoscopist evaluates

the alignment of this box around the polyp to assess the accuracy measurement outcome.

Importantly, throughout these operations, the endoscopist remains blinded to the size

estimated by POSEIDON. The endoscopist also reports polyp cases where they are unable to

obtain a proper measurement.

Study population:

All adult patients with screening or surveillance colonoscopies that do not match the

exclusion criteria will be asked for informed consent.

Intervention:

Upon polyp identification by the endoscopist, the visual assessment will be conducted,

followed by obtaining a satisfactory measurement using POSEIDON when possible, as described

in the AI methods section. To eliminate potential learning bias and optimize efficiency, the

examiner will be blinded to the immediate measurement result. Finally, after both

measurements are obtained, an instrument tip of known size will be positioned adjacent to the

polyp, which is to be later used for obtaining the gold-standard polyp size.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Adult patients

- Scheduled for colonoscopy

Exclusion Criteria:

Patient Level:

- Inflammatory Bowel Disease

- Familiar Polyposis Syndrome

Data Level

- Failure to initialize system before examination

- Missing image instrument placed next to polyp to obtain gold standard

Studien-Rationale

Primary outcome:

1. Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation (Time Frame - Through study completion, an average of 5 months):
The error between gold standard polyp size and estimation using POSEIDON and optical estimation will be compared in pairs for the same polyps.

Secondary outcome:

1. Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation for different size categories (Time Frame - Through study completion, an average of 5 months):
Polyps will be split into size categories based on national and international guidelines. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison

2. Error of size estimation for colorectal polyps using POSEIDON versus physician optical evaluation for polyps with different histologies (Time Frame - Through study completion, an average of 5 months):
Polyps will be split into based on their histological evaluation. The study will assess the errors of both POSEIDON and optical estimation within each group through pairwise comparison.

3. Rate of change in guideline-suggested follow-up interval based purely on detected polyp size. (Time Frame - Through study completion, an average of 5 months):
The study determines follow-up intervals based on three international standards, solely considering polyp size estimated by the two methods.

4. Percentage of polyps where endoscopists failed to obtain POSEIDON measurement. (Time Frame - Through study completion, an average of 5 months):
Evaluation of the percentage polyps for which the endoscopist was unable to obtain a proper measurement with the proposed method.

Geprüfte Regime

POSEIDON size estimation software with the EndoMind polyp detection system:
Polyp size estimation using the POSEIDON software and bounding boxes of the EndoMind polyp detection system.

Quelle: ClinicalTrials.gov

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