Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps

NCT05699954 | Completed

• 1 other identifier: ONZ-2022-0488
• Study Type: observational
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. If submucosal invasive cancer (SMI) is suspected, careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy. Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcomes (e.g. piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease). Studies from the field of psychology show that humans are often capable of making correct decision based on their Blink (first) impression. It is also suggested that this Blink impression is based on experience and training. This might suggest that experienced or specialist endoscopist are better at diagnosing SMI within colorectal polyp at Blink impression. The investigators hypothesize that by training the Blink impression, endoscopist of varying experience are able to detect cancer within LNPCPs. This can be proven by assessing the Blink impression of endoscopist of varying experience regarding the presence of SMI within LNPCPs. Increasing the accuracy of the determination of SMI within colon polyps would directly translate into improvements in patient care and outcome. For example, if SMI is present and is not suspected, patients may undergo unnecessary endoscopic procedures for an LNPCP which will eventually require surgery anyway (inconvenience, delayed correct treatment). If the incorrect technique is performed in the context of superficial SMI, adequate assessment of complete excision or extent and type of SMI may not be possible and a patient who would otherwise have been cured may require surgery anyway (under-treatment, below standard of care outcome, delay to treatment). Conversely, if SMI is suspected in its absence patients may undergo unnecessary surgery, increased healthcare spends and mortality (over-treatment, unnecessary risk). If the presence of SMI could be accurately determined in real-time using endoscopic imaging, delays to treatment, over-treatment and the associated morbidity for patients could be avoided.

Conditions

Colorectal Polyp; Colorectal Cancer; Colono

Outcome Measures

Primary Outcomes (1)

• The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.

  The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs, using the Blink (first) impression when analysing images of LNPCPs.

  Through study completion, Study is open for 2 weeks

Secondary Outcomes (1)

• Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.

  Through study completion, Study is open for 2 weeks

Interventions

Presence of Blink impression features for cancer in colorectal polyps DIAGNOSTIC_TEST

1. 20 LNPCPs will be collected from the UZ Ghent database (all LNPCPs, ICF present). 2. A survey will be made where participant endoscopist will be informed about the study. They will here be asked for electronic consent. 3. The survey asks for demographics of the participant endosopists (experience, country where they work). 4. The last part of the survey is where the 20 images of the LNPCPs are shown. After evere image 4 questions are asked. Is this a colorectal polyp? (Yes/No) * Is your Blink (first) Impression that this polyp contains cancer? (Yes/No) * If "yes", why do you think that? (Free comment box) * What treatment would you recommend for this polyp? (piecemeal endoscopic mucosal resection/endoscopic submucosal disection/surgery) 5. Study will be closed after 2 weeks. 6. Data analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Endoscopists of varying experience (trainees, consultants, expert endoscopists, interventional endoscopists. * Patients with LNPCPs

You may qualify if:

• Endoscopists of varying abilities and grades (participant endoscopist) that consents electronically
• Patients with LNPCPs who signed the ICF of UZ Ghent Hospital for the anonymous use images of their polyp taken during colonoscopy

You may not qualify if:

• Image of inadequate quality as per opinion of the principal investigator
• Patient does not consent to data collection for the study (participant patient)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)