An interventional study of CC followed by EC and EC followed by CC in Colorectal Neoplasms, sponsored by Radboud University Medical Center. Status unknown at 3 sites in 2 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-02-01.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Diagnostic
The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.
Rationale: Population screening programs for colorectal cancers (CRC) are increasingly adapted as a public health initiative with the primary goal to prevent CRC and CRC related deaths. [2-4] The ultimate benefit of CRC screening relies on the detection and resection of (pre-)malignant colon lesions, and for this colonoscopy is the preferred modality. Recently, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon.[5-9] Most ICs are suspected to arise from missed colon lesions during colonoscopy. The retrograde approach of colonic inspections may contribute to colon lesions remaining undetected as it limits visualization of the proximal sides of haustral folds and flexures. Endocuff Vision® is a single-use, disposable medical device designed to improve the detection of colon lesions. The 'finger-like' projections of the device provide fold retraction allowing the visualization of otherwise hidden anatomical areas. Additionally, Endocuff Vision® may improve scope tip stability and prevent scope slippage.
Objectives:
Study design: This multicenter, randomized, same-day, back-to-back tandem colonoscopy trial will include four separate study groups: group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed by CC, and group D; EAC followed by EAC.
Study population: Patients between the ages of 40 and 75-years referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy.
Main study parameters/endpoints: The primary endpoint of the study will be AMR.
Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain) and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.
Exclusion Criteria:
2 x conventional colonoscopy (CC), back-to-back design
Device: 2x CC
Conventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design
Device: CC followed by EC
Endocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design
Device: EC followed by CC
2 x Endocuff Vision-assisted colonoscopy
Device: 2x EC
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
EC = endocuff assisted colonoscopy
CC = conventional colonoscopy
Adenoma miss rate (%)
To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)
Time frame: 18 months
Adenoma detection rate (%)
To compare adenoma detection rates (ADR) between Endocuff Vision®-assisted and CC.
Time frame: 18 months
Mean number of adenomas detected per colonoscopy procedure
Mean number of adenomas detected per colonoscopy procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
Time frame: 18 months
Number of sessile serrated lesions per procedure
Number of sessile serrated lesions per procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.
Time frame: 18 months
Total number of colon lesions found during first and second examination
These polyps will be compared for size, colon distribution (coecum, ascending, transversum, descending, sigmoïd or rectum), morphologic (Paris classification) and histopathological characteristics (Vienna classification)
Time frame: 18 months
Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
To compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR throughout the trial (to assess a learning curve) between CC and EC
Time frame: 18 months
Cecal intubation rate
To compare cecal intubation rates between both techniques.
Time frame: 18 months
Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)
To compare BBPS scores between both techniques. A BBPS score of 2 or more in each colon segment is considered adequate.
Time frame: 18 months
Procedure times (minutes)
To compare procedure times; total procedure time, insertion time, mean polypectomy time, withdrawal time)
Time frame: 18 months
Number of severe adverse events
To compare the number of severe adverse events between study groups. 1 month follow-up
Time frame: 18 months
Sedation and analgesia use; type and amount
To compare the use of sedation and analgesia between study groups. Type of sedation and analgesia and amount will be compared
Time frame: 18 months
Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.
To compare post-colonoscopy surveillance intervals applying European and US surveillance guidelines.
Time frame: 18 months
To compare patient reported outcomes e.g. pain
Visual Analog Scale 2 days and 1 month after the procedure
Time frame: 18 months
Plan to share: Undecided
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Radboud University Medical Center