Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

Overview

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

Full Title of Study: “Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 15, 2018

Detailed Description

This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.

Number of patients:

2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).

Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).

Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.

The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.

A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.

Interventions

  • Device: Endocuff Vision (ECV) second generation
    • Colonoscopy performed with the use of “Endocuff Vision (ECV) second generation” at the tip of the scope

Arms, Groups and Cohorts

  • Active Comparator: Colonoscopy with Endocuff Vision (ECV)
    • ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)
  • No Intervention: Standard colonoscopy
    • Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)

Clinical Trial Outcome Measures

Primary Measures

  • Adenoma detection rate (ADR)
    • Time Frame: during procedure
    • rate (%) of colonoscopies with one or more adenoma detected

Secondary Measures

  • Polyp detection rate (PDR)
    • Time Frame: during procedure
    • rate (%) of colonoscopies with one or more polyp detected
  • Advanced neoplasia detection rate (ANDR)
    • Time Frame: during procedure
    • rate (%) of colonoscopies with one or more advanced neoplasia detected
  • Serrated polyp detection rate (SPDR)
    • Time Frame: during procedure
    • rate (%) of colonoscopies with one or more serrated polyp detected
  • Morbidity: perforation rate (%)
    • Time Frame: 21 days after procedure
    • Perforation rates (%)
  • Morbidity: bleeding rate (%)
    • Time Frame: 21 days after procedure
    • Bleeding rates (%)
  • caecal intubation rate (%)
    • Time Frame: during procedure
    • caecal intubation rate (complete colonoscopy)
  • Time to reach caecum (sec)
    • Time Frame: during procedure
    • Time to reach caecum from the beginning of the procedure (in seconds)
  • withdrawal time (sec)
    • Time Frame: during procedure
    • withdrawal time of the scope from the caecum to the end of the procedure (in seconds)

Participating in This Clinical Trial

Inclusion Criteria

1. Patient scheduled for total colonoscopic exploration, during the period study

2. Patient over or equal to 18 years

3. ASA 1, ASA 2, ASA 3

4. No participation in another clinical study

5. Certificate of non opposition signed

Exclusion Criteria

1. Patient under 18 years old

2. ASA 4, ASA 5

3. Pregnant woman

4. Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.

5. Inflammatory bowel disease

6. Known colonic stenosis

7. Diverticulitis less than 6 weeks old

8. Patient unable to give consent or protected by law

9. Opposition expressed for inclusion in the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Société Française d’Endoscopie Digestive
  • Provider of Information About this Clinical Study
    • Principal Investigator: KARSENTI, MD, Principal Investigator – Société Française d’Endoscopie Digestive

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