Clinical trial NCT03418948: Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
Official title: Comparison of Adenoma Miss Rate and Adenoma Detection Rate Between Endocuff Vision®-Assisted Colonoscopy and Conventional Colonoscopy: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Norgine
First posted: 2018-02-01
Enrollment: 708
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma miss rate (%)
timeFrame: 18 months
Secondary outcomes:
measure: Adenoma detection rate (%)
timeFrame: 18 months
measure: Mean number of adenomas detected per colonoscopy procedure
timeFrame: 18 months
measure: Number of sessile serrated lesions per procedure
timeFrame: 18 months
measure: Total number of colon lesions found during first and second examination
timeFrame: 18 months
measure: Difference in ADR (learning curve first 20% and last 20% by each colonoscopist)
timeFrame: 18 months
measure: Cecal intubation rate
timeFrame: 18 months
measure: Bowel cleansing levels; using the Boston Bowel Preparation Scale (BBPS) ranging from 0-9)
timeFrame: 18 months
measure: Procedure times (minutes)
timeFrame: 18 months
measure: Number of severe adverse events
timeFrame: 18 months
measure: Sedation and analgesia use; type and amount
timeFrame: 18 months
measure: Post-polypectomy surveillance guidelines; difference in surveillance intervals after the first and second procedure.
timeFrame: 18 months
measure: To compare patient reported outcomes e.g. pain
timeFrame: 18 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital,
state: Haidari
city: Athens
country: Greece
facility: 417 Army Veterans Hospital
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter D Siersema, MD
role: PRINCIPAL_INVESTIGATOR
References: