Virtual Scale Function SCALE EYE: Variability and Systematic Differences (SCALE-EYE)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Polyp of Colon

Treatments: Device: SCALE EYE

Study type: Interventional

Funder types: Other

Identifiers

NCT05499546

NL81269.018.22

Details and patient eligibility

About

Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.

Full description

This study is designed as a single center prospective study. Polyp size measurements using SCALE EYE will be compared with several other polyp size measurement techniques: size measurements by endoscopists without a reference ('carpenters eye') , size measurements by endoscopists with an opened snare (of known size) as reference and size measurements by the pathologist during histopathological analysis.

During screening colonoscopies, detected polyps (maximum of four per colonoscopy) will be measured using all three different colonoscopy measurement techniques. This will be done by experienced endoscopists (endoscopist accredited for colonoscopies within the national colorectal cancer screening program). Since endoscopists measure polyps in multiple ways, consecutive measurements of the same polyp will be biased. For this reason, all polyp size measurements will be recorded on video. The video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight trainees (depending on availability) in a randomized order. The size estimations based on these video recordings will be used for further analysis. Histopathological analysis and size measurements of the resected polyps will be performed by pathologists with expertise in gastrointestinal pathology. Variability and systematic differences in polyp size measurement between different measurements methods will be assessed.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Screening colonoscopy after positive fecal immunochemical test (FIT) within the Dutch colorectal cancer screening program
• Signed informed consent

Exclusion criteria

• Diagnosis of inflammatory bowel disease, Lynch syndrome or (serrated) polyposis syndrome

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Intervention arm

Experimental group

Description:

All patients within the study are included in the intervention arm: polyp detected within these patients will be measured according to the study protocol using four different methods.

Treatment:

Device: SCALE EYE