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

Sponsor: University Hospital Virgen de las Nieves • ClinicalTrials.gov ID: NCT07874152

Registry updated: 2026-10-14
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Description

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.

Interventions

  • High-definition white light endoscopy (WLE) (Diagnostic test)
    Standard high-definition white light assessment of the post-polypectomy scar (EVIS X1, Olympus).
  • Texture and color enhancement imaging (TXI) (Device)
    Image-enhancement mode of the EVIS X1 platform (Olympus) enhancing texture, brightness and color.
  • Narrow-band imaging (NBI) (Device)
    Virtual chromoendoscopy mode of the EVIS X1 platform (Olympus). Added by protocol amendment.
  • GI Genius (CADe) (Device)
    Artificial intelligence computer-aided detection system (Medtronic) used during white light assessment of the scar.

Eligibility criteria

Inclusion Criteria: * Age 18 years or older. * Previous endoscopic resection (endoscopic mucosal resection or endoscopic submucosal dissection) of a colorectal lesion ≥15 mm, performed 3 to 6 months before the surveillance colonoscopy. * Histology of the resected lesion showing an adenoma or a sessile serrated lesion. * Referral for endoscopic review of the post-polypectomy scar. * Signed written informed consent. Exclusion Criteria: * Resected lesion \<15 mm. * Histology of the resected lesion other than adenoma or sessile serrated lesion. * Incomplete previous resection, or uncertainty about the completeness of the previous resection. * Patients who, because of age or comorbidity, are not candidates for endoscopic surveillance. * Failure to complete the study protocol, including biopsy of the scar.

Conditions

Colorectal Polyps

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record