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| Name | Class |
|---|---|
| Olympus | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narrow-Band Imaging (NBI) | Active Comparator | Inspection with Narrow-Band Imaging(NBI) versus inspection with standard white light(usual care) |
|
| Standard White Light | Active Comparator | Inspection with Standard White Light versus Narrow-Band Imaging(NBI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspection with Narrow-Band Imaging(NBI) | Procedure | Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Serrated Lesions Proximal to the Sigmoid Colon | Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy. | During the colonoscopy procedure |
| 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). | During the colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon | Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon). | During the colonoscopy procedure |
| Total Number of Conventional Adenomas in Entire Colon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beltway Surgical Center | Indianapolis | Indiana | 46280 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25952085 | Derived | Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Serrated Lesions Proximal to the Sigmoid Colon | Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy. | Posted | Number | Serrated Lesions | During the colonoscopy procedure |
|
38 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lahr | Indiana University | 317-948-0724 | rlahr@iu.edu |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| D062048 | Narrow Band Imaging |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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|
| Standard White Light | Procedure | Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy. |
|
|
Total quantity of adenomas found during colonoscopy procedure. |
| During the colonoscopy procedure |
| Number of Conventional Adenomas Per Patient in Entire Colon | Average number of adenomas (located anywhere throughout the colon) found per patient. | During the colonoscopy procedure |
| Patients With 1 or More Conventional Adenomas | Patient had to have at least 1 polyp that was an adenoma. | During the colonoscopy procedure |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tobacco use | Count of Participants | Participants |
|
| ASA risk class | ASA 1 -- a normal healthy patient ASA 2 -- a patient with mild systemic disease ASA 3 -- a patient with severe systemic disease | Count of Participants | Participants |
|
| Indication | Count of Participants | Participants |
|
| Time from end of colon prep to procedure start | Mean | Standard Deviation | Hours |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Number of serrated lesions | During the colonoscopy procedure |
|
|
|
| Secondary | Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon | Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon). | Posted | Count of Participants | Participants | During the colonoscopy procedure |
|
|
|
| Secondary | Total Number of Conventional Adenomas in Entire Colon | Total quantity of adenomas found during colonoscopy procedure. | Posted | Number | Conventional Adenomas | During the colonoscopy procedure |
|
|
|
| Secondary | Number of Conventional Adenomas Per Patient in Entire Colon | Average number of adenomas (located anywhere throughout the colon) found per patient. | Posted | Mean | Standard Deviation | Adenomas per patient | During the colonoscopy procedure |
|
|
|
| Secondary | Patients With 1 or More Conventional Adenomas | Patient had to have at least 1 polyp that was an adenoma. | Posted | Count of Participants | Participants | During the colonoscopy procedure |
|
|
|
| 0 |
| 399 |
| 0 |
| 399 |
| 0 |
| 399 |
| EG001 | 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. | 0 | 401 | 0 | 401 | 0 | 401 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Greater than or equal to 10mm |
|
| Greater than or equal to 10mm |
|
| Greater than or equal to 10mm |
|
| Greater than or equal to 10mm |
|
| Greater than or equal to 10mm |
|