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

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01572428
• Collaborator: Olympus (Industry)
• Enrollment: 898
• Location: 1
• Arms: 2
• Duration (Months): 39.2
• Patients Per Site Per Month: 22.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: Inspection with Narrow-Band Imaging(NBI); Procedure: Standard White Light	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 898 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Randomized Controlled Trial Comparing the Use of Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jul 7, 2014
• Actual Study Completion Date: Jul 7, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Narrow-Band Imaging (NBI) Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care)	Procedure: 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.; Other Names: Colonoscopy
Active Comparator: Standard White Light Inspection with Standard White Light versus Narrow-Band Imaging(NBI)	Procedure: 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.; Other Names: Colonoscopy ; Procedure: 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.; Other Names: Colonoscopy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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).

2. Total Number of Conventional Adenomas in Entire Colon [During the colonoscopy procedure]

   Total quantity of adenomas found during colonoscopy procedure.

3. 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.

4. Patients With 1 or More Conventional Adenomas [During the colonoscopy procedure]

   Patient had to have at least 1 polyp that was an adenoma.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beltway Surgical Center	Indianapolis	Indiana	United States	46280

Sponsors and Collaborators

• Indiana University
• Olympus

Investigators

• Principal Investigator: Douglas K Rex, MD, Indiana University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Douglas K. Rex, Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT01572428
• Other Study ID Numbers: 1012-17
• First Posted: Apr 6, 2012
• Last Update Posted: Aug 8, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Douglas K. Rex, Professor, Indiana University: Proximal Colon Cancer; Serrated Colon Lesions; Narrow Band Imaging
• Additional relevant MeSH terms: Colonic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	402	402
COMPLETED	399	401
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	399	401	800
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.08 (8.294)	61.41 (8.251)	61.25 (8.269)
Sex: Female, Male (Count of Participants)
Female	216 54.1%	240 59.9%	456 57%
Male	183 45.9%	161 40.1%	344 43%
Race/Ethnicity, Customized (Count of Participants)
White	339 85%	329 82%	668 83.5%
Black or African American	54 13.5%	63 15.7%	117 14.6%
Other	4 1%	3 0.7%	7 0.9%
Unknown	2 0.5%	6 1.5%	8 1%
Region of Enrollment (participants) [Number]
United States	399 100%	401 100%	800 100%
Tobacco use (Count of Participants)
Current	53 13.3%	44 11%	97 12.1%
Past	130 32.6%	123 30.7%	253 31.6%
Never	216 54.1%	234 58.4%	450 56.3%
ASA risk class (Count of Participants)
1	52 13%	63 15.7%	115 14.4%
2	230 57.6%	226 56.4%	456 57%
3	117 29.3%	112 27.9%	229 28.6%
Indication (Count of Participants)
Screening	212 53.1%	203 50.6%	415 51.9%
Surveillance	149 37.3%	162 40.4%	311 38.9%
Other	38 9.5%	36 9%	74 9.3%
Time from end of colon prep to procedure start (Hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Hours]	6.12 (2.41)	6.10 (1.99)	6.11 (2.21)

Outcome Measures

1. Primary Outcome

Title	Total Number of Serrated Lesions Proximal to the Sigmoid Colon
Description	Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
Any size	204	158
Greater than 5mm in size	95	59
Greater than or equal to 10mm	39	20

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
Any size	0.51 (1.18)	0.39 (0.76)
Greater than 5mm in size	0.24 (0.70)	0.15 (0.45)
Greater than or equal to 10mm	0.10 (0.42)	0.05 (0.23)

3. Secondary Outcome

Title	Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon
Description	Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
Any size	105 26.3%	107 26.7%
Greater than 5mm in size	60 15%	45 11.2%
Greater than or equal to 10mm	25 6.3%	19 4.7%

4. Secondary Outcome

Title	Total Number of Conventional Adenomas in Entire Colon
Description	Total quantity of adenomas found during colonoscopy procedure.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
All Sizes	438	434
Greater than 5mm in size	110	90
Greater than or equal to 10mm	29	22

5. Secondary Outcome

Title	Number of Conventional Adenomas Per Patient in Entire Colon
Description	Average number of adenomas (located anywhere throughout the colon) found per patient.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
All Sizes	1.1 (1.61)	1.08 (1.72)
Greater than 5mm in size	0.28 (0.62)	0.22 (0.67)
Greater than or equal to 10mm	0.07 (0.30)	0.05 (0.27)

6. Secondary Outcome

Title	Patients With 1 or More Conventional Adenomas
Description	Patient had to have at least 1 polyp that was an adenoma.
Time Frame	During the colonoscopy procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Narrow-Band Imaging (NBI)	Standard White Light
Arm/Group Description	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.	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.
Measure Participants	399	401
Any size	202 50.6%	189 47.1%
Greater than 5mm in size	84 21.1%	61 15.2%
Greater than or equal to 10mm	25 6.3%	18 4.5%

Adverse Events

Time Frame	38 months
Arm/Group Title	Narrow-Band Imaging (NBI)		Standard White Light
Arm/Group Description	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.		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.
All Cause Mortality
	Narrow-Band Imaging (NBI)		Standard White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/399 (0%)		0/401 (0%)
Serious Adverse Events
	Narrow-Band Imaging (NBI)		Standard White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/399 (0%)		0/401 (0%)
Other (Not Including Serious) Adverse Events
	Narrow-Band Imaging (NBI)		Standard White Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/399 (0%)		0/401 (0%)

Limitations/Caveats

Endoscopists weren't blinded to the type of light being used during withdrawal, which is a limitation of all detection studies. Number of SSPs were not specifically an endpoint of the study, but rather the entire serrated class of polyps.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.