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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: 2x CC; Device: CC followed by EC; Device: EC followed by CC; Device: 2x EC

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 708
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11521
    • Recruiting
    • 417 Army Veterans Hospital
    • Contact: george Alexandrakis
  • Haidari
    • Athens, Haidari, Greece, GR-12462
      • Recruiting
      • "Attikon" University General Hospital,
      • Contact: Ioannis Papanikolaou, MD
• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Recruiting
      • Radboud University Medical Center
      • Contact: Kelly E van Keulen, MD; Phone Number: +31611910792; Email: kelly.vankeulen@radboudumc.nl
      • Contact: Peter D Siersema, MD; Phone Number: +31 (0)24 36 16999; Email: peter.siersema@radboudumc.nl
      • Principal Investigator: Peter D Siersema, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2 x CC; 2 x conventional colonoscopy (CC), back-to-back design	Device: 2x CC; CC = conventional colonoscopy
ACTIVE_COMPARATOR: CC followed by EC; Conventional colonoscopy followed by Endocuff Vision- assisted colonoscopy, back-to-back design	Device: CC followed by EC; CC = conventional colonoscopy EC = endocuff assisted colonoscopy
ACTIVE_COMPARATOR: EC followed by CC; Endocuff Vision-assisted colonoscopy followed by conventional colonoscopy, back-to-back design	Device: EC followed by CC; CC = conventional colonoscopy EC = endocuff assisted colonoscopy
ACTIVE_COMPARATOR: 2 x EC; 2 x Endocuff Vision-assisted colonoscopy	Device: 2x EC; EC = endocuff assisted colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma miss rate (%)	To compare adenoma miss rates (AMR) between Endocuff Vision®-assisted colonoscopy (EAC) and conventional colonoscopy (CC)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate (%)	To compare adenoma detection rates (ADR) between Endocuff Vision®-assisted and CC.	18 months
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
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
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
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
Cecal intubation rate	To compare cecal intubation rates between both techniques.	18 months
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
Procedure times (minutes)	To compare procedure times; total procedure time, insertion time, mean polypectomy time, withdrawal time)	18 months
Number of severe adverse events	To compare the number of severe adverse events between study groups. 1 month follow-up	18 months
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
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
To compare patient reported outcomes e.g. pain	Visual Analog Scale 2 days and 1 month after the procedure	18 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Norgine

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2017
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (ACTUAL): February 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: EXCEED study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No