Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial

Colorectal Neoplasms Clinical Trial

— EXCEED  

Official title:

Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03418948
• Other study ID #: EXCEED study
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2017
• Last updated: January 25, 2018
• Start date: December 8, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: December 2017
• Source: Radboud University
• Contact: Kelly van Keulen, MD
• Phone: +31611910792
• Email: kelly.vankeulen[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this international multicenter study is to compare the adenoma detection rate and adenoma miss rate of conventional and Endocuff Vision-assisted colonoscopy.

Description:

Rationale: Population screening programs for colorectal cancers (CRC) are increasingly adapted as a public health initiative with the primary goal to prevent CRC and CRC related deaths. [2-4] The ultimate benefit of CRC screening relies on the detection and resection of (pre-)malignant colon lesions, and for this colonoscopy is the preferred modality. Recently, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon.[5-9] Most ICs are suspected to arise from missed colon lesions during colonoscopy. The retrograde approach of colonic inspections may contribute to colon lesions remaining undetected as it limits visualization of the proximal sides of haustral folds and flexures. Endocuff Vision® is a single-use, disposable medical device designed to improve the detection of colon lesions. The 'finger-like' projections of the device provide fold retraction allowing the visualization of otherwise hidden anatomical areas. Additionally, Endocuff Vision® may improve scope tip stability and prevent scope slippage.

Objectives:

1. To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)

2. To compare adenoma detection rates (ADR) between EAC and CC

3. To assess whether a proposed increased ADR and reduced AMR with EAC is indeed due to the fold-flattening device or merely a consequence of the second colonoscopy procedure performed.

4. To assess the clinical relevance of the polyps missed during the first colonoscopy procedure.

Study design: This multicenter, randomized, same-day, back-to-back tandem colonoscopy trial will include four separate study groups: group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed by CC, and group D; EAC followed by EAC.

Study population: Patients between the ages of 40 and 75-years referred for screening (non-IFOBT based), diagnostic or surveillance colonoscopy.

Main study parameters/endpoints: The primary endpoint of the study will be AMR.

Secondary endpoints include; ADR, mean number of adenomas detected per colonoscopy procedure, number of sessile serrated polyps, the total number of colon lesions found during the first and second examination (which will be compared for size, colon distribution, morphologic and histopathological characteristics), cecal intubation rates, bowel cleansing levels, procedure times, sedation use, (severe) adverse events, patient reported outcome (pain) and post-colonoscopy surveillance intervals applying European and United states surveillance guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 708
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients, aged between 40 and 75-years old, referred and scheduled for either screening (non-FIT/gFOBT based), diagnostic or surveillance colonoscopy.

Exclusion Criteria:

• Prior surgical resection of any portion of the colon or a history of radiotherapy for any abdominal or pelvic disease.

• Personal history of colon cancer or polyposis syndrome.

• Familial adenomatous polyposis (FAP)

• Known colitis or suspicion of colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis).

• Lower gastro-intestinal bleeding requiring acute intervention.

• Suspicion of large bowel obstruction or toxic megacolon.

• Prior incomplete colonoscopy (not including insufficient preparation).

• Patients referred for a therapeutic procedure or assessment of a known non-resected lesion.

• Not sufficiently corrected anticoagulation disorders

• Poor general condition (>3 American Society of Anesthesiologist)

• Overweight (>120 kg)

• Inability to provide informed consent.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• CC followed by EC
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
• EC followed by CC
CC = conventional colonoscopy EC = endocuff assisted colonoscopy
• 2x EC
EC = endocuff assisted colonoscopy
• 2x CC
CC = conventional colonoscopy

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital,	Athens	Haidari
Greece	417 Army Veterans Hospital	Athens
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Norgine

Countries where clinical trial is conducted

Greece,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma miss rate (%)	To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)	18 months
Secondary	Adenoma detection rate (%)	To compare adenoma detection rates (ADR) between Endocuff Vision®-assisted and CC.	18 months
Secondary	Mean number of adenomas detected per colonoscopy procedure	Mean number of adenomas detected per colonoscopy procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.	18 months
Secondary	Number of sessile serrated lesions per procedure	Number of sessile serrated lesions per procedure. This will be calculated after the first and second procedure to assess if there is a significant increase.	18 months
Secondary	Total number of colon lesions found during first and second examination	These polyps will be compared for size, colon distribution (coecum, ascending, transversum, descending, sigmoïd or rectum), morphologic (Paris classification) and histopathological characteristics (Vienna classification)	18 months
Secondary	Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)	To compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR throughout the trial (to assess a learning curve) between CC and EC	18 months
Secondary	Cecal intubation rate	To compare cecal intubation rates between both techniques.	18 months
Secondary	Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)	To compare BBPS scores between both techniques. A BBPS score of 2 or more in each colon segment is considered adequate.	18 months
Secondary	Procedure times (minutes)	To compare procedure times; total procedure time, insertion time, mean polypectomy time, withdrawal time)	18 months
Secondary	Number of severe adverse events	To compare the number of severe adverse events between study groups. 1 month follow-up	18 months
Secondary	Sedation and analgesia use; type and amount	To compare the use of sedation and analgesia between study groups. Type of sedation and analgesia and amount will be compared	18 months
Secondary	Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.	To compare post-colonoscopy surveillance intervals applying European and US surveillance guidelines.	18 months
Secondary	To compare patient reported outcomes e.g. pain	Visual Analog Scale 2 days and 1 month after the procedure	18 months