Colon Polyps Clinical Trial
Official title:
Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)
Colon cancer is the third most common cancer in western society. To prevent colon cancer it
is recommended for people to undergo a screening colonoscopy at the age of fifty. The
purpose of the colonoscopy is to remove polyps, since some of these lesions are
precancerous. Precancerous polyps are called adenomas. This method of prevention is
effective, but the standard colonoscopy currently used does not detect all polyps. Studies
have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish
precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard
colonoscopy. This results in all polyps being removed at time of colonoscopy, even the
benign polyps.
To help improve the detection of colon polyps new endoscopic technologies have been
developed. These technologies include high definition white light (HDWL)and high definition
narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during
colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance
as well as seeing small blood vessels and capillaries.
The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate
when compared to the current standard colonoscopy. In addition to develop a classification
system to help better differentiate between precancerous polyps and their benign
counterparts using HDWL and HDNBI.
II. Hypothesis:
1. The use of NBI colonoscopy will reduce the miss rate for colon polyps compared to
standard white light imaging.
2. HDWl and HDNBI are more accurate than standard colonoscopy for the classification of
adenomatous polyps in comparison to other non-premalignant polyps.
III. Specific Aims:
1. Compare the miss rate of standard white light imaging compared to NBI for detection of
colon polyps with NBI
2. Estimate the accuracy of standard white light, HDWL and HDNBI imaging modes for the
classification of adenomatous (premalignant) versus non-adenomatous (hyperplastic,
inflammatory, normal) polyps.
3. Examine the inter-observer agreement for classification of adenomatous versus
non-adenomatous polyps based on standard, NBI and HDWL imaging.
IV. Research Design and Methods:
4.1 Study Design: A prospective phase II cross-over trial. Patients will undergo both
procedures (standard, NBI) back to back under conscious sedation. The order of the procedure
will be randomized.
4.2 Setting: The study will take place at Mayo Clinic Jacksonville, Division of
Gastroenterology, an expert center in the diagnosis and treatment of colon polyps.
4.3 Study Subjects All patients scheduled for colonoscopy at Mayo Clinic Jacksonville will
be screened for eligibility using inclusion and exclusion criteria. The patients that are
deemed eligible will be offered participation in the study. Informed consent will be
obtained and the participant will be registered in our database. Prior to consent the
participant will be made aware of the investigative nature of the study, alternatives,
risks, and benefits.
4.4 Eligibility Criteria
Inclusion Criteria:
1. Age 18 years or older.
2. Informed written consent.
Exclusion Criteria:
1. History of inflammatory bowel disease.
2. Patients with severe cardiopulmonary disease precluding colonoscopy.
3. Presence of conditions not allowing for polypectomy or biopsy (e.g. coagulation
disorder).
4. Known familial polyposis syndrome (FAP, HNPCC, Juvenile polyposis, etc)
5. Sub-optimal preparation for the procedure, which will be determined by patient history
or based on the initial colonoscopy.
6. Pregnancy
4.5 Procedure and Data Collections
A. Pre-procedure:
All patients will be prepared for colonoscopy with the standard preparation and will be
scheduled to have the procedure at Mayo Clinic Jacksonville. The principal investigator (PI)
will screen eligible patients based on medical history, physical exam and laboratory data on
day of procedure.
Patients typically arrive at the registration area at least 60 minutes before start of
scheduled procedure. A GI endoscopy nurse will prepare patients in the standard manner and
intravenous access will be placed. Eligible patients will be offered informed consent by the
study PI or designee. Patients who agree to participate in the study will sign informed
consent and will be registered in the database. A log with only non-identifiable (e.g.
patients # 1) will also be maintained of eligible patients who decline to participate. The
GI endoscopy nurse will monitor patient's vitals before, during and after procedure as per
standard protocol.
B. Procedure:
The exams will be performed back to back with a standard colonoscope and an ETMI colonoscope
provided by Olympus. The order of the first and second procedure will be randomized
according to a list prepared by the statistician using randomly permuted blocks to ensure
equal numbers of patients are randomized to the two groups. All patients will be sedated
with meperidine or fentanyl and midazolam to achieve conscious sedation. Each procedure will
be preformed by a different endoscopist. The endoscopist will be either the P.I. supervised
by a GI staff physician or solely by one of the five GI staff physicians. During the initial
colonoscopy all visualized polyps will be noted, photographed, and removed. When the ETMI
colonoscope is used, all polyps will be photographed using these modes (HDWL, HDNBI). The
NBI portion of the exam will be performed using the MB-046 cap to further enhance
stabilization of the focal length of the colonoscope.
The second procedure will be done with the same level of careful inspection as the first
although we not specifically regiment the time of withdrawal beyond what the endoscopist
feels is necessary for a careful examination. During the second colonoscopy all visualized
polyps will be noted, photographed and removed. During the first procedure, the time will be
evaluated with a stopwatch. The stopwatch will start when the endoscopist begins pull-back
at the cecum and end when the scope is removed from the anal verge. The clock will be
stopped during washing of the bowel, polypectomy, biopsy or any other therapeutic maneuver.
At the end of the first procedure, the endoscopist will be informed of the withdrawal and
inspection time and every effort will be made to match this to the second procedure. Time
will be recorded similarly for the second procedure. Polyps will be classified as
pedunculated, raised-sessile (rounded) or flat. Flat polyps will be further classified
according to the Paris endoscopic classification 14.
C. Post-procedure:
After the procedure all patients will be brought to the recovery and monitored as per
standard protocol. Participants will be given discharge instructions as per protocol and
also be provided with information to contact the P.I. if any problems should occur. Any post
procedure complication will be reviewed on weekly intervals.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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