Colorectal Polyp
Conditions
Keywords
screening, colonoscopy, surveillance
Brief 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.
Detailed description
Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety. Study design: Multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. With a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. Enrollment will conclude once 138 polyps are included in the study. Study population: All adult patients with screening or surveillance colonoscopies will be asked for informed consent. Polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. Up to 3 polyps per patient can be included in this study. Intervention: Optical assessment will be performed upon identification of the polyp. Then, measurement with AccuMeasure and biopsy forceps will be performed in a randomized order. The endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.
Interventions
DEVICEAccuMeasure
intracolonoscopy measurement of polyps using a laser-based device
Sponsors
Radboud University Medical Center
Tel-Aviv Sourasky Medical Center
Erasmus Medical Center
Bnai Zion Medical Center
NYU Langone Health
Indiana University Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
the endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements. Even so, all pathologist assessments will be done independent of the study allocation.
Intervention model description
As optical assessment of polyps has a high interobserver variability, the order of polyps' size measurement using biopsy forceps or AM will be randomized per patient. Therefore, this study consists of two arms: Optical polyp size assessment, followed by biopsy forceps and then AM measurement (1), and optical assessment, followed by AM measurement and then biopsy forceps assisted assessment (2) (Figure 1).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohens' Kappa coefficient | at colonoscopy | interobserver agreement between AccuMeasure and biopsy forceps assisted measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with adverse events up to 30 days post colonoscopy | 30 days post colonoscopy | Number of Participants with adverse events |
| Absolute size differences | at colonoscopy | Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement; |
| Time for measurement | at colonoscopy | Time for measurement with AccuMeasure related to number of measurements performed |
| Endoscopist advised surveillance interval | At colonoscopy | Endoscopist advised surveillance interval based on optical assessment during colonoscopy, on measurement with an open biopsy forceps, and on measurement with AccuMeasure |
Countries
Netherlands, United States
Outcome results
None listed