Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate (Cuff-Bercy)

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice

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)

Study Overview

• Status: Completed
• Conditions: Colonic Polyp; Colonoscopy; Colonic Adenoma
• Intervention / Treatment: Device: Endocuff Vision (ECV) second generation

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.

• Study Type: Interventional
• Enrollment (Actual): 2059
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Charenton-le-Pont, France, 94220
    • Clinique PARIS-BERCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colonoscopy with Endocuff Vision (ECV); ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)	Device: Endocuff Vision (ECV) second generation; Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope
No Intervention: Standard colonoscopy; Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate (ADR)	rate (%) of colonoscopies with one or more adenoma detected	during procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive

Publications and helpful links

General Publications

• Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: November 12, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma Detection Rate; Endocuff
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 2017-A00549-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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