Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Post-polypectomy scar: comparing four imaging methods to find residual tissue

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)

Run by University Hospital Virgen de las Nieves · NCT07874152 · Data updated 2026-11-12

Doctors will test four imaging methods to see which best detects leftover or recurrent tissue at colonoscopy scars after large polyps were removed.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment206 (estimated)
SponsorUniversity Hospital Virgen de las Nieves
Academic / other
Locations2 sites (Granada, Granada and 1 other locations)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 30, 2026
Study endsJune 30, 2027
Registry record updatedOctober 14, 2026
Trial IDNCT07874152 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older who had a colorectal lesion ≥15 mm resected by EMR or ESD 3 to 6 months earlier and now are referred for scar review with histology showing adenoma or sessile serrated lesion.

Probably not a fit

Patients whose scars show no residual tissue or whose lesions do not benefit from imaging enhancements may receive standard care without additional benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study compares high-definition white light endoscopy, TXI, NBI, and a computer-aided detection system for detecting residual or recurrent tissue at post-polypectomy scars. Each scar is evaluated using all four techniques in random order by different experts, with biopsies taken from suspicious areas and histology used as the reference standard. Adults with a recent piecemeal EMR or ESD of colorectal lesions ≥15 mm are eligible, provided they are referred for scar review 3 to 6 months after treatment. The goal is to identify the imaging combination that yields the highest detection accuracy for residual neoplasia. The study is conducted at Hospital Universitario Virgen de las Nieves in Granada, Spain, led by its University Hospital gastroenterology department.

Why it matters

Potential benefit: If successful, the approach could improve accuracy in detecting residual or recurrent tissue, potentially reducing missed recurrences and guiding more effective endoscopic retreatment.

How similar studies have gone: Previous studies suggest that advanced imaging and CADe can improve detection of residual tissue, but head-to-head comparisons among TXI, WLE, NBI, and CADe in post-EMR scars are novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Department of Gastroenterology and Hepatology. Virgen de las Nieves University Hospitals
    Granada, Granada, Spain
    Recruiting
  • Virgen de las Nieves University Hospital. Department of Gastroenterology and Hepatology
    Granada, Granada, Spain
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.