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

Primary Purpose

Colonic Adenoma, Colonic Polyp, Colonoscopy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endocuff Vision (ECV) second generation
Sponsored by
Société Française d'Endoscopie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Adenoma focused on measuring Adenoma Detection Rate, Endocuff, Colonoscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique PARIS-BERCY

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Colonoscopy with Endocuff Vision (ECV)

Standard colonoscopy

Arm Description

ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)

Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)

Outcomes

Primary Outcome Measures

Adenoma detection rate (ADR)
rate (%) of colonoscopies with one or more adenoma detected

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2017
Last Updated
January 26, 2019
Sponsor
Société Française d'Endoscopie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT03344055
Brief Title
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate
Acronym
Cuff-Bercy
Official Title
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
November 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Société Française d'Endoscopie Digestive

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Colonic Polyp, Colonoscopy
Keywords
Adenoma Detection Rate, Endocuff, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2059 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy with Endocuff Vision (ECV)
Arm Type
Active Comparator
Arm Description
ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)
Arm Title
Standard colonoscopy
Arm Type
No Intervention
Arm Description
Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation)
Intervention Type
Device
Intervention Name(s)
Endocuff Vision (ECV) second generation
Intervention Description
Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope
Primary Outcome Measure Information:
Title
Adenoma detection rate (ADR)
Description
rate (%) of colonoscopies with one or more adenoma detected
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Polyp detection rate (PDR)
Description
rate (%) of colonoscopies with one or more polyp detected
Time Frame
during procedure
Title
Advanced neoplasia detection rate (ANDR)
Description
rate (%) of colonoscopies with one or more advanced neoplasia detected
Time Frame
during procedure
Title
Serrated polyp detection rate (SPDR)
Description
rate (%) of colonoscopies with one or more serrated polyp detected
Time Frame
during procedure
Title
Morbidity: perforation rate (%)
Description
Perforation rates (%)
Time Frame
21 days after procedure
Title
Morbidity: bleeding rate (%)
Description
Bleeding rates (%)
Time Frame
21 days after procedure
Title
caecal intubation rate (%)
Description
caecal intubation rate (complete colonoscopy)
Time Frame
during procedure
Title
Time to reach caecum (sec)
Description
Time to reach caecum from the beginning of the procedure (in seconds)
Time Frame
during procedure
Title
withdrawal time (sec)
Description
withdrawal time of the scope from the caecum to the end of the procedure (in seconds)
Time Frame
during procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient scheduled for total colonoscopic exploration, during the period study Patient over or equal to 18 years ASA 1, ASA 2, ASA 3 No participation in another clinical study Certificate of non opposition signed Exclusion Criteria: Patient under 18 years old ASA 4, ASA 5 Pregnant woman Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. Inflammatory bowel disease Known colonic stenosis Diverticulitis less than 6 weeks old Patient unable to give consent or protected by law Opposition expressed for inclusion in the study
Facility Information:
Facility Name
Clinique PARIS-BERCY
City
Charenton-le-Pont
ZIP/Postal Code
94220
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32209605
Citation
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.
Results Reference
derived

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Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

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