Colorectal Polyps
Conditions
Keywords
virtual scale endoscopy, biopsy forceps, optical assessment, colorectal cancer
Brief summary
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population. Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
Detailed description
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated. Study design: A multicenter, randomized, parallel group, endoscopist blinded study. Study population: The unit of analysis is the colorectal polyp rather than the participants, approximately 289 colorectal polyps are planned to be included. Based on an expected detection rate of roughly 1.20 polyps per colonoscopy in the study population, approximately 241 participants aged 55-80 years old, who are referred for screening or surveillance colonoscopy at the participating study sites and have signed the informed consent form (ICF), will be included into the study. Polyps of all shapes (flat, sessile, pedunculated) that are found during colonoscopy and are smaller than 25 mm, as judged by the endoscopist using optical assessment, are considered eligible for inclusion. Intervention: Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist and then in a randomized order measured by biopsy-forceps assisted measurement and SCALE-EYE measurement. Primary outcome measurement: The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard. Secondary outcome measurements: * The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment by endoscopists for polyp size measurement. * Sustainability (reduction of colonoscopies, the colonoscopy-associated waste and carbon footprint). * The learning curve, this will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty. * The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard. * Safety, in terms of (serious) adverse events up to 30 days post-procedure.
Interventions
DEVICESCALE-EYE (1)
Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement.
DEVICESCALE-EYE (2)
Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants will be split in two groups who will in parallel to each other undergo both SCALE-EYE measurement and biopsy-forceps assisted measurement, but there will be randomization in the order of measuring. So approximately half of the participants, in whom polyps are found, will first undergo SCALE-EYE measurement and then biopsy-forceps assisted measurement, and the other half of the participants will first undergo biopsy-forceps assisted measurement and then SCALE-EYE measurement.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 55-80 * Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy * Polyps of all forms ≤25 mm as assessed by the endoscopist
Exclusion criteria
* No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present * Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) \<2 per segment) * Intraprocedural complications, not caused by the study device * Known or suspected inflammatory bowel disease (IBD) * Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis) * Ileoanal pouch and anastomosis * History of radiation or chemotherapy for colorectal lesions * Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)) * Pregnancy * No Informed consent (IC) possible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCALE-EYE diagnostic performance versus biopsy-forceps | Immediately after the screening and/or surveillance colonoscopy | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCALE-EYE diagnostic performance versus optical assessment | Immediately after the screening and/or surveillance colonoscopy | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment. |
| Sustainability | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) | The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement. |
| Learning curve | Immediately after the screening and/or surveillance colonoscopy | The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty. |
| Surveillance interval agreement | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) | The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared. |
| (Serious) adverse events | Up to 30 days post-colonoscopy | Serious adverse events (SAEs) and adverse events (AEs) will be summarized by proportions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Personal/family history of polyps or colorectal cancer (CRC) | At baseline (after informed consent is signed) | Personal/family history of polyps or colorectal cancer (CRC) of participant - yes or no |
| Type of colonoscopy | At baseline (after informed consent is signed) | Type of colonoscopy (screening or surveillance) |
| Type of endoscope used | During the screening and/or surveillance colonoscopy | Type of endoscope used (SCALE-EYE equipped endoscope number) |
| Cecum intubation rate | At baseline | Cecum intubation rate in percentage (%) |
| Sedation | During the screening and/or surveillance colonoscopy | Sedation (yes or no and which type) |
| Time needed for measurement | During the screening and/or surveillance colonoscopy | Time needed for measurement (minutes for SCALE-EYE and biopsy-forceps assisted measurement) |
| Experienced difficulty | During the screening and/or surveillance colonoscopy | Experienced difficulty of SCALE-EYE measurement (scale 1-10; 1 = very easy and 10 = very difficult) |
| Reason of unsuccessful SCALE-EYE measurement | During the screening and/or surveillance colonoscopy | Reasons include: * Unclear surroundings of polyp (i.e., feces, folds) * Peristalsis * Difficult-to-reach location * Mechanical difficulties (e.g. error graphic of SCALE-EYE) * Failed cleaning of endoscope lens/build-in laser * Software malfunction (freeze, crash, other) * Other |
| Withdrawal time | Immediately after the screening and/or surveillance colonoscopy | Withdrawal time (minutes) |
| Polyp information | During the screening and/or surveillance colonoscopy | Polyp location, morphology and method of polyp removal (i.e., hot/cold-snare polypectomy, EMR, ESD) |
| Use of butyl scopolamine | During the screening and/or surveillance colonoscopy | Use of butyl scopolamine (yes or no) |
| Boston Bowel Preparation Score (BBPS) | During the screening and/or surveillance colonoscopy | BBPS (at least a score of 6 is required with a score of 2 in each colon segment) |
| Endoscopist experience | At baseline | Endoscopist experience (experienced = \>1000 independent colonoscopies; regular = 300 - 1000) |
| Age | At baseline (after informed consent is signed) | Age in years of participant |
| Sex | At baseline (after informed consent is signed) | Sex (male/female) of participant |
Countries
Netherlands
Outcome results
None listed