Virtual Scale Function SCALE EYE: Variability and Systematic Differences
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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 videotaped. The video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight fellows (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 the four measurements methods will be assessed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention arm
|
Device: SCALE EYE
Polyp size measurement using the SCALE EYE functionality
|
Outcome Measures
Primary Outcome Measures
- Differences in residual variance expert endoscopists [Through study completion, an average of 3 months]
The difference in residual variance (variability) between (1) polyp size measurement with SCALE EYE and (2) polyp size measurement using an opened snare (of known size) as reference.
Secondary Outcome Measures
- Differences in residual variance expert endoscopists [Through study completion, estimation: 3 months]
The difference in residual variance (variability) between polyp size measurement with (1) the SCALE EYE functionality, (2) polyp size measurement without reference and (3) polyp size measurement during histopathological analysis.
- Systematic differences expert endoscopists [Through study completion, estimation: 3 months]
The systematic difference in polyp size measurements between (1) the SCALE EYE functionality and the other measurement techniques: (2) polyp size measurement without reference, (3) polyp size measurement with an opened snare as a visual reference and (4) polyp size measurement during histopathological analysis.
- Differences in residual variance and systematic differences fellow endoscopists [Through study completion, estimation: 3 months]
Aforementioned parameters / outcomes (and primary study parameter) based on assessment by fellow endoscopists (for other analyses assessment by experts will be used)
- Inter-observer variability [Through study completion, estimation: 3 months]
Inter-observer variability within techniques (residual variance)
- SCALE EYE measurement accuracy compared to snare measurement [Through study completion, estimation: 3 months]
The accuracy of the SCALE EYE functionality for predicting the size of polyps. Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all experts endoscopists will be used for the comparison.
- SCALE EYE measurement accuracy compared to snare measurement for different polyp size groups [Through study completion, estimation: 3 months]
The accuracy of the SCALE EYE functionality for predicting polyp size for different polyp size categories (1-5 mm vs. 6-9 mm vs. >10 mm). Accuracy is defined as the percentage of correctly predicted polyp sizes with the SCALE EYE functionality when polyp size measurement with an opened snare is considered as reference standard. Polyp size will be assigned as correctly predicted if the polyp size measurement with SCALE EYE lies within a 25% margin of error. The mean of the polyp size measurements by all expert endoscopists will be used to assign the polyp size category.
- SCALE EYE success rate [Through study completion, estimation: 3 months]
The proportion of successful polyp size measurements by SCALE EYE during live endoscopy
- SCALE EYE measurement time [Through study completion, estimation: 3 months]
Average time to manoeuver SCALE EYE during live endoscopy (i.e. time to perform measurement of one polyp)
- SCALE EYE satisfaction score [Through study completion, estimation: 3 months]
Satisfaction score for usage of SCALE EYE (scale from 1-10)
Eligibility Criteria
Criteria
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
-
Patients who are unwilling or unable to give informed consent
-
Polyps greater than 20 mm (based on visual size etsimation by the executing endoscopist)
-
If polyp is removed in a way other than cold snare resection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Academic Medical Centre | Amsterdam | Noord-Holland | Netherlands | 1105AZ |
Sponsors and Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
- Principal Investigator: Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL81269.018.22