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

July 27, 2018 updated by: Cancer Prevention and Research Institute, Italy

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Florence, Italy, 50139
        • Recruiting
        • Screening Unit, Oncological Network, Prevention and Research Institute
        • Contact:
      • Milan, Italy, 20142
      • Padova, Italy, 35127
      • Padova, Italy, 35131
        • Active, not recruiting
        • Veneto Tumor Registry, Local Health Unit 4, Veneto Region
      • Rovigo, Italy, 45100
        • Not yet recruiting
        • Santa Maria della Misericordia Hospital, Local Health Unit 5 Polesana, Veneto Region
        • Contact:
      • Treviso, Italy, 31100
      • Turin, Italy, 10126
        • Not yet recruiting
        • Molinette Hospital, Città della Salute e della Scienza University Hospital Company
        • Contact:
      • Verona, Italy, 37047
    • BL
      • Belluno, BL, Italy, 32100
    • Belluno
      • Feltre, Belluno, Italy, 32032
    • Cremona
      • Crema, Cremona, Italy, 26013
    • Vicenza
      • Arzignano, Vicenza, Italy, 36071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient values
Time Frame: 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.
Day 1
Exam values
Time Frame: 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.
Day 1
Number of lesions
Time Frame: Day 1
Comparison of polyps number between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Day 1
Size
Time Frame: Day 1
Comparison of polyps size between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Day 1
Anatomical site
Time Frame: Day 1
Comparison of polyps anatomical site between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Day 1
Histological diagnoses
Time Frame: Through study completion, an average of 1 year
Comparison of polyps histological diagnoses between the standard colonoscopy arm and the Endocuff Vision colonoscopy arm.
Through study completion, an average of 1 year
Colonoscopist' age
Time Frame: Through study completion, an average of 1 year
Analysis of the involved colonoscopists' age.
Through study completion, an average of 1 year
Colonoscopist' years of experience
Time Frame: Through study completion, an average of 1 year
Analysis of the involved colonoscopists' years of experience.
Through study completion, an average of 1 year
Colonoscopist' specialization
Time Frame: Through study completion, an average of 1 year
Analysis of the involved colonoscopists' specialization.
Through study completion, an average of 1 year
Colonoscopist' number of exams in the previous year
Time Frame: Through study completion, an average of 1 year
Analysis of the involved colonoscopists' number of exams in the previous year.
Through study completion, an average of 1 year
Colonoscopists' ADR in the previous year
Time Frame: Through study completion, an average of 1 year
Analysis of the involved colonoscopists' ADR in the previous year.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Prevention and Research Institute, Italy

Collaborators

Veneto Tumor Registry, Azienda Zero, Padua, Italy

Investigators

  • Study Director: Gianni Amunni, MD, Oncological Network, Prevention and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2018

Primary Completion (ANTICIPATED)

April 1, 2019

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (ACTUAL)

August 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F17G18000000007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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