Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

Colonoscopy Clinical Trial

— Cuff-Bercy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344055
• Other study ID #: 2017-A00549-44
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: November 15, 2018

Study information

• Verified date: January 2019
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2059
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colonic Adenoma
• Colonic Polyp
• Colonic Polyps
• Colonoscopy

Intervention

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

Locations

Country	Name	City	State
France	Clinique PARIS-BERCY	Charenton-le-Pont

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

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