ITAvision: Adenoma Detection Rate With Endocuff-Assisted Colonoscopy - an Italian Trial

Sponsor

Cancer Prevention and Research Institute, Italy (Other)

Overall Status

Unknown status

CT.gov ID

NCT03612674

Collaborator

Veneto Tumor Registry, Azienda Zero, Padua, Italy (Other)

2,100

Enrollment

Locations

Arms

15.9

Anticipated Duration (Months)

175

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colorectal Adenoma Colorectal Polyp Colorectal Neoplasms	Procedure: Standard colonoscopy Device: ARC Endocuff Vision	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.Subjects will be randomized in two arms: a control-arm and an experimental-arm. Then arms data will be compared.

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).

Primary Purpose:

Screening

Official Title:

Adenoma Detection Rate With ARC Endocuff Vision Assisted Colonoscopy vs. Standard Colonoscopy in Colorectal Cancer Screening: a Multicenter Randomized Italian Study

Actual Study Start Date :

Apr 4, 2018

Anticipated Primary Completion Date :

Apr 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard colonoscopy (S) A standard colonoscopy will be performed.	Procedure: Standard colonoscopy Current standard of care colonoscopy.
Experimental: AEV assisted colonoscopy (E) Colonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed.	Device: ARC Endocuff Vision Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.

Arm

Intervention/Treatment

Active Comparator: Standard colonoscopy (S)

A standard colonoscopy will be performed.

Procedure: Standard colonoscopy

Current standard of care colonoscopy.

Experimental: AEV assisted colonoscopy (E)

Colonoscopy with ARC Endocuff Vision attached to the top of the scope will be performed.

Device: ARC Endocuff Vision

Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.

Outcome Measures

Primary Outcome Measures

Adenoma Detection Rate (ADR) [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 Outcome Measures

Patient values [Day 1]
Comparison of ADR according to patient's age, sex, screening history (first or subsequent test) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Exam values [Day 1]
Comparison of cecum intubation, patient discomfort (with Visual Analogue Scale -VAS) between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm. The Visual Analogue Scale goes from 1 to 10, where 1 is the absence pain and 10 is severe pain. Number 1 represents the best outcome measure, while 10 is the worst result for this outcome measure.
Number of lesions [Day 1]
Comparison of polyps number between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Size [Day 1]
Comparison of polyps size between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Anatomical site [Day 1]
Comparison of polyps anatomical site between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Histological diagnoses [Through study completion, an average of 1 year]
Comparison of polyps histological diagnoses between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Colonoscopist' age [Through study completion, an average of 1 year]
Analysis of the involved colonoscopists' age.
Colonoscopist' years of experience [Through study completion, an average of 1 year]
Analysis of the involved colonoscopists' years of experience.
Colonoscopist' specialization [Through study completion, an average of 1 year]
Analysis of the involved colonoscopists' specialization.
Colonoscopist' number of exams in the previous year [Through study completion, an average of 1 year]
Analysis of the involved colonoscopists' number of exams in the previous year.
Colonoscopists' ADR in the previous year [Through study completion, an average of 1 year]
Analysis of the involved colonoscopists' ADR in the previous year.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Maria del Prato, Local Health Unit 1 Dolomiti, Veneto Region	Feltre	Belluno	Italy	32032
2	San Martino Hospital, Local Health Unit 1 Dolomiti, Veneto Region	Belluno	BL	Italy	32100
3	Maggiore Hospital, Crema Territorial Health Care Company, Lombardia Region	Crema	Cremona	Italy	26013
4	Cazzavillan Hospital, Local Health Unit 8 Berica, Veneto Region	Arzignano	Vicenza	Italy	36071
5	Screening Unit, Oncological Network, Prevention and Research Institute	Florence		Italy	50139
6	San Paolo Hospital Company - University Campus	Milan		Italy	20142
7	Sant'Antonio Hospital, Local Health Unit 6 Euganea, Veneto Region	Padova		Italy	35127
8	Veneto Tumor Registry, Local Health Unit 4, Veneto Region	Padova		Italy	35131
9	Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region	Rovigo		Italy	45100
10	Ca' Foncello Hospital, Local Health Unit 2 Marca Trevigiana, Veneto Region	Treviso		Italy	31100
11	Molinette Hospital, Città della Salute e della Scienza University Hospital Company	Turin		Italy	10126
12	San Bonifacio Hospital, Local Health Unit 9 Scaligera, Veneto Region	Verona		Italy	37047