Clinical trial NCT03612674: Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial
Official title: Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Colorectal Adenoma
Colorectal Polyp
Colorectal Neoplasms
Keywords: Mass screening
Adenoma detection rate
ARC Endocuff Vision
Colonoscopy
Lead sponsor: Cancer Prevention and Research Institute, Italy
Sponsor class: OTHER
Collaborators: name: Veneto Tumor Registry, Azienda Zero, Padua, Italy
First posted: 2018-08-02
Enrollment: 2100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.
Primary purpose: SCREENING

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.

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.

Previous researches have studied the performance of colonoscope distal attachment devices. More specifically, a 2016 meta-analysis of more than 5,000 patients demonstrates that, compared to traditional colonoscopy, the use of an Endocuff device improves ADR without any adverse effect on procedural efficiency or increased risk of significant adverse events. Moreover, Facciorusso et al. in 2017 assessed only a modest improvement in ADR by using distal attachment devices, especially in low-performing endoscopists, while in 2018 Williet showed, with moderate-quality evidence, an improvement in ADR with EAC without major adverse events, especially for operators with low-to-moderate ADR.

Second-generation AEV is a soft plastic cap, to be applied on the top of the colonoscopy. The cap has a propylene-made cylindrical core, with a single row of flexible arms. During the colon intubation procedure the device is nearly invisible, while in the retraction phase the arms begin to work, opening up and pulling the colon walls, stretching convoluted tracts.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Patient values
timeFrame: Day 1
measure: Exam values
timeFrame: Day 1
measure: Number of lesions
timeFrame: Day 1
measure: Size
timeFrame: Day 1
measure: Anatomical site
timeFrame: Day 1
measure: Histological diagnoses
timeFrame: Through study completion, an average of 1 year
measure: Colonoscopist' age
timeFrame: Through study completion, an average of 1 year
measure: Colonoscopist' years of experience
timeFrame: Through study completion, an average of 1 year
measure: Colonoscopist' specialization
timeFrame: Through study completion, an average of 1 year
measure: Colonoscopist' number of exams in the previous year
timeFrame: Through study completion, an average of 1 year
measure: Colonoscopists' ADR in the previous year
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Feltre
country: Italy
facility: Santa Maria del Prato, Local Health Unit 1 Dolomiti, Veneto Region
state: Belluno
city: Belluno
country: Italy
facility: San Martino Hospital, Local Health Unit 1 Dolomiti, Veneto Region
state: BL
city: Crema
country: Italy
facility: Maggiore Hospital, Crema Territorial Health Care Company, Lombardia Region
state: Cremona
city: Arzignano
country: Italy
facility: Cazzavillan Hospital, Local Health Unit 8 Berica, Veneto Region
state: Vicenza
city: Florence
country: Italy
facility: Screening Unit, Oncological Network, Prevention and Research Institute
city: Milan
country: Italy
facility: San Paolo Hospital Company - University Campus
city: Padova
country: Italy
facility: Sant'Antonio Hospital, Local Health Unit 6 Euganea, Veneto Region
city: Padova
country: Italy
facility: Veneto Tumor Registry, Local Health Unit 4, Veneto Region
city: Rovigo
country: Italy
facility: Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region
city: Treviso
country: Italy
facility: Ca' Foncello Hospital, Local Health Unit 2 Marca Trevigiana, Veneto Region
city: Turin
country: Italy
facility: Molinette Hospital, Città della Salute e della Scienza University Hospital Company
city: Verona
country: Italy
facility: San Bonifacio Hospital, Local Health Unit 9 Scaligera, Veneto Region
Study officials:
affiliation: Oncological Network, Prevention and Research Institute
name: Gianni Amunni, MD
role: STUDY_DIRECTOR
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