CompletedNot Applicable

Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance

United States, Netherlands138 participantsStarted 2023-06-19

Plain-language summary

Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Adult patients (\>18 years) * Scheduled for screening, surveillance, or diagnostic colonoscopy * Polyps of all forms ≤ 25mm as assessed by the endoscopist Exclusion Criteria: * • Therapeutic colonoscopy; * Inflammatory bowel disease (IBD); * American Society of Anesthesiologists (ASA) score of \>3; * Inadequately corrected anticoagulation disorder or anticoagulation medication use; * Inability to provide informed consent; * Inadequate bowel preparation (Boston bowel preparation scale score \[BBPS\] \<2 per segment); * No polyps identified during colonoscopy or only small (\<5mm) hyperplastic rectal polyps; * Intraprocedural complications, not caused by the study device.

What they're measuring

Cohens' Kappa coefficient

Timeframe: at colonoscopy

Trial details

NCT IDNCT05489380

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-28