Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,100
- Locations
- 24
- Primary Endpoint
- Adenoma Detection Rate (ADR)
Study Overview
Brief Summary
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.
Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.
Detailed Description
In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
It has been demonstrated that screening with fecal occult blood test (FOBT) significantly reduces mortality for CRC. Currently, population-based CRC screening programs using FOBT have been or are heading towards being implemented in many European countries. Fecal immunochemical test (FIT) has been adopted by most Italian Regions as the standard screening test, with total colonoscopy as diagnostic assessment in subjects resulted FIT positive. A significant impact of FIT-based screening on CRC mortality reduction has been observed in an Italian region after 10 years from screening implementation. Moreover, two studies carried out in a Northern-central area of Italy have shown a reduction in CRC incidence in subjects who attended FIT screening programs as compared to non-attendees.
Increasing colonoscopy quality is critical for the screening impact among population. Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy. ADR is defined as the proportion of colonoscopies during which at least one adenoma can be detected. A polish study showed that ADR was an independent predictor of the risk of interval colorectal cancer after screening colonoscopy. ADR has shown a direct correlation with: operator experience, cecal intubation, quality of bowel preparation, patient sedation, endoscope withdrawal time, presence of flat, depressed or subtle lesions, ability to visualize the proximal side of haustral folds, flexures (blind spots), rectal valves, and ileocecal valves.
On the other hand, colonoscopy is considered the gold standard for adenoma detection, but it has shown some limits. Data from colonoscopy studies showed that up to 25% of polyps were missed during colonoscopy and up to 8% of CRCs occurred within 3 years after a previous colonoscopy. Moreover, recent studies have shown that cancers post-colonoscopy are most likely due to missed lesions, rather than being new lesions.
For these reasons, industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Masking Description
Participants will not be informed about diagnostic procedure in order to evaluate the acceptability of the exam with or without the studied device (in fact at the end of the examination care provider will ask participant about perceived pain during the procedure through the VAS score).
Eligibility Criteria
- Ages
- 50 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject with a positive FIT result in the frame of national screening program
Exclusion Criteria
- •Subjects younger than 50 years old
- •Active Inflammatory Bowel Disease
- •Known condition of cholic stenosis
- •Acute diverticulitis
- •Patient not able to sign a informed consent form
Arms & Interventions
AEV assisted colonoscopy (E)
Colonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed.
Intervention: ARC Endocuff Vision (Device)
Standard colonoscopy (S)
A standard colonoscopy will be performed.
Intervention: Standard colonoscopy (Procedure)
Outcomes
Primary Outcomes
Adenoma Detection Rate (ADR)
Time Frame: Through study completion, an average of 1 year
Comparison of the number of adenomas (ADR) detected per subject between the Endocuff Vision colonoscopy and the standard colonoscopy.
Secondary Outcomes
- Patient values(Day 1)
- Exam values(Day 1)
- Number of lesions(Day 1)
- Size(Day 1)
- Anatomical site(Day 1)
- Histological diagnoses(Through study completion, an average of 1 year)
- Colonoscopist' age(Through study completion, an average of 1 year)
- Colonoscopist' years of experience(Through study completion, an average of 1 year)
- Colonoscopist' specialization(Through study completion, an average of 1 year)
- Colonoscopist' number of exams in the previous year(Through study completion, an average of 1 year)
- Colonoscopists' ADR in the previous year(Through study completion, an average of 1 year)