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RECRUITING
NCT07874152
NA

White Light, TXI, NBI and Computer-Aided Detection for Recurrence at Post-EMR Scars (PRINCESS)

Sponsor: University Hospital Virgen de las Nieves

View on ClinicalTrials.gov

Summary

Large colorectal polyps removed piece by piece (piecemeal endoscopic mucosal resection) can recur at the resection scar. Detecting this residual or recurrent tissue at surveillance colonoscopy is essential, because it can then be treated endoscopically. Recurrence can be subtle, and the best way to examine the scar has not been established. This study compares four ways of examining post-polypectomy scars: high-definition white light endoscopy (WLE) texture and color enhancement imaging (TXI, Olympus) narrow-band imaging (NBI, Olympus) an artificial intelligence computer-aided detection system (GI Genius, Medtronic) Each scar is examined with all four techniques, in random order. A different expert endoscopist performs each technique, without knowing the findings of the others. Biopsies are then taken from every scar, and any suspicious tissue is removed. Histology is the reference standard. The main goal is to determine which technique, or combination of techniques, has the highest sensitivity and negative predictive value for detecting recurrence.

Official title: Diagnostic Accuracy of White Light Endoscopy, Texture and Color Enhancement Imaging (TXI), Narrow-Band Imaging (NBI) and Artificial Intelligence (GI Genius) for the Detection of Adenomatous Recurrence at Post-Polypectomy Scars: a Prospective, Randomized Crossover, Blinded Study (PRINCESS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2024-12-01

Completion Date

2027-06-30

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

High-definition white light endoscopy (WLE)

Standard high-definition white light assessment of the post-polypectomy scar (EVIS X1, Olympus).

DEVICE

Texture and color enhancement imaging (TXI)

Image-enhancement mode of the EVIS X1 platform (Olympus) enhancing texture, brightness and color.

DEVICE

Narrow-band imaging (NBI)

Virtual chromoendoscopy mode of the EVIS X1 platform (Olympus). Added by protocol amendment.

DEVICE

GI Genius (CADe)

Artificial intelligence computer-aided detection system (Medtronic) used during white light assessment of the scar.

Locations (2)

Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals

Granada, Granada, Spain

Virgen de las Nieves University Hospital. Department of Gastroenterology and Hepatology

Granada, Granada, Spain