Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for the detection of colorectal lesions in comparison with the Exera III study
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope
Secondary outcome
- Sensitivity of the Olympus Extra Wide Angle View colonoscope for the
detection of advanced colorectal adenomas in comparison to data from the Exera
III study, overall and in subgroups (adenoma size, form, location).
- Evaluation of caecal insertion time using the Olympus Extra Wide Angle View
colonoscope with responsive insertion technology in compariso to caecal
insertion times gained during the Exera III study.
- Evaluation of ileocaecal valve insertion success using the Olympus Extra Wide
Angle View colonoscope in comparison to ileocaecal valve insertion success
gained during the Exera III study.
- Evaluation of retroflex view using the Olympus Extra Wide Angle View
colonoscope in comparison to the retroflex view gained during the Exera III
study.
- Adverse events of the Olympus Extra Wide Angle View colonoscope in comparison
to the Exera III study.
Background summary
Colonoscopy is currently the reference standard for detecting colorectal
neoplasia and colorectal cancer (CRC). Several tandem studies have reported a
substantial adenoma miss rate of 20-26%, and approximately 2-12% for polyps
larger than 10mm. Recently a landmark paper was published, that demonstrated
that patients that underwent a screening colonoscopy performed by an
endoscopist with an adenoma detection rate (ADR) of greater than 20% had a
significantly lower chance of developing an interval carcinoma than when scoped
by an endoscopist with an ADR lower than 20%. However, an ADR of 20% is not
always accomplished.
There are several reasons for missing colonic lesions, including the anatomical
location of polyps on the proximal side of the folds. Over the past few years
multiple developments have been introduced in colonoscopies to assess this
difficulty by providing a wide angle view. Several studies are performed
focusing on wide angle colonoscopy. Some studies did show improvement in ADR,
but others did not. These disappointing results might be explained be
displaying of the endoscopically obtained image as multiple images and
therefore time-consuming and not user-friendly.
Olympus developed a new wide angle colonoscope, the Extra Wide Angle View
colonoscope CF-Y0048. In this colonoscope the side view and forward view are
incorporated in one image with minimal transition. This image provides in total
a 235 degree view and therefore looks backwards on the proximal side of the
valves.
Before new techniques can be introduced in daily clinical practice, feasibility
and accuracy need to be assessed in order to prove their value. The current
study will assess the feasibility of the Olympus Extra Wide Angle View CF-Y0048
colonoscope in the detection of colorectal adenomas. These results will be
compared to the results gained in the two groups (190 and 165 colonoscopes)
from the Exera III study.
Study objective
Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for
the detection of colorectal lesions in comparison with the Exera III study
Study design
Prospective multicenter cohort study, with the Exera II as controlgroup
Intervention
Colonoscopy with the Olympus Extra Wide Angle View Colonoscope
Study burden and risks
Besides the common colonoscopy risk are there no additional risks expected
Meibergdreef 9
Amsterdam 1100 AZ
NL
Meibergdreef 9
Amsterdam 1100 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age greater than or equal to 18 years
- High risk for colorectal cancer: FOBT positive, personal or familial (first degree relatives) history of colorectal cancer or colorectal adenoma, patients with symptoms suggestive of colorectal neoplasm: rectal bleeding, recent change in frequency and consistency of stools.
- Status 1 and 2 of the ASA classification (fit for colonoscopy)
- Signed informed consent
Exclusion criteria
- Mental or physical condition that can adversely affect the preparation or conduct of the examination or which precludes compliance with the study and / or device instructions.
- Inability to undergo bowel cleansing for colonoscopy.
- Prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or cholecystectomy).
- Known or suspicion of inflammatory bowel disease.
- Known large (> 2 cm) colorectal polyp for polypectomy
- Colonic diverticulosis complication within 3 months prior inclusion.
- Very high risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease (Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC)).
- Coagulation abnormalities or taking drugs affecting coagulation.
- Life threatening conditions
- Status > 2 of the ASA classification (see Appendix I).
- Renal insufficiency or any contraindication or medication contraindicating the administration of bowel cleansing.
- Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46414.018.13 |
| OMON | NL-OMON22448 |