Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01572428

Enrollment

898

Registered

2012-04-06

Start date

2011-04-30

Completion date

2014-07-07

Last updated

2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Proximal Colon Cancer, Serrated Colon Lesions, Narrow Band Imaging

Brief summary

This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

Detailed description

This is a randomized controlled trial comparing the use of Narrow-Band Imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Narrow-Band Imaging has anecdotally been used to highlight the appearance of these lesions. This study will test whether Narrow-Band Imaging increases the detection of serrated lesions in a randomized controlled trial.

Interventions

PROCEDUREInspection with Narrow-Band Imaging(NBI)

Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.

PROCEDUREStandard White Light

Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 50-85 * Intact colon and rectum * American Society of Anesthesiology risk class 1, 2 or 3

Exclusion criteria

* No prior surgical resection of colon or rectum

Design outcomes

Primary

Measure	Time frame	Description
Total Number of Serrated Lesions Proximal to the Sigmoid Colon	During the colonoscopy procedure	Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient	During the colonoscopy procedure	Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).

Secondary

Measure	Time frame	Description
Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon	During the colonoscopy procedure	Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Total Number of Conventional Adenomas in Entire Colon	During the colonoscopy procedure	Total quantity of adenomas found during colonoscopy procedure.
Number of Conventional Adenomas Per Patient in Entire Colon	During the colonoscopy procedure	Average number of adenomas (located anywhere throughout the colon) found per patient.
Patients With 1 or More Conventional Adenomas	During the colonoscopy procedure	Patient had to have at least 1 polyp that was an adenoma.

Countries

United States

Participant flow

Pre-assignment details

Number of patients enrolled(898) differs from number of patients started(804). This is because 94 patients were enrolled but not randomized for various reasons such as inadequate bowel preparation, research personnel/scope not being available, ineligibility of patient per colonoscopist discretion, patient withdrawing consent prior to randomization.

Participants by arm

Arm	Count
Narrow-Band Imaging (NBI) Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care) Inspection with Narrow-Band Imaging(NBI): Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.	399
Standard White Light Inspection with Standard White Light versus Narrow-Band Imaging(NBI) Standard White Light: Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.	401
Total	800

Baseline characteristics

Characteristic	Narrow-Band Imaging (NBI)	Total	Standard White Light
Age, Continuous	61.08 Years STANDARD_DEVIATION 8.294	61.25 Years STANDARD_DEVIATION 8.269	61.41 Years STANDARD_DEVIATION 8.251
ASA risk class 1	52 Participants	115 Participants	63 Participants
ASA risk class 2	230 Participants	456 Participants	226 Participants
ASA risk class 3	117 Participants	229 Participants	112 Participants
Indication Other	38 Participants	74 Participants	36 Participants
Indication Screening	212 Participants	415 Participants	203 Participants
Indication Surveillance	149 Participants	311 Participants	162 Participants
Race/Ethnicity, Customized Black or African American	54 Participants	117 Participants	63 Participants
Race/Ethnicity, Customized Other	4 Participants	7 Participants	3 Participants
Race/Ethnicity, Customized Unknown	2 Participants	8 Participants	6 Participants
Race/Ethnicity, Customized White	339 Participants	668 Participants	329 Participants
Region of Enrollment United States	399 participants	800 participants	401 participants
Sex: Female, Male Female	216 Participants	456 Participants	240 Participants
Sex: Female, Male Male	183 Participants	344 Participants	161 Participants
Time from end of colon prep to procedure start	6.12 Hours STANDARD_DEVIATION 2.41	6.11 Hours STANDARD_DEVIATION 2.21	6.10 Hours STANDARD_DEVIATION 1.99
Tobacco use Current	53 Participants	97 Participants	44 Participants
Tobacco use Never	216 Participants	450 Participants	234 Participants
Tobacco use Past	130 Participants	253 Participants	123 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 399	0 / 401
other Total, other adverse events	0 / 399	0 / 401
serious Total, serious adverse events	0 / 399	0 / 401

Outcome results

Primary

Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient

Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).