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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Virgen de las Nieves
NCT07874152 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 st

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📋 Eligibility rules (as published)
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.
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What it tests

  • High-definition white light endoscopy (WLE)
  • Texture and color enhancement imaging (TXI)
  • Narrow-band imaging (NBI)
  • GI Genius (CADe)
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Where

2 sites
Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals
Granada, Spain
Virgen de las Nieves University Hospital. Department of Gastroenterology and Hepatology
Granada, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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