Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

Study Overview
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Brief Summary
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Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.

Official Title
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Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: Narrow band imaging
* Other: Chromoendoscopy
* Other: High definition white light endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years Referral for screening, surveillance or diagnostic colonoscopy Exclusion Criteria: Inflammatory bowel disease History of colorectal cancer or colon resection Indication of positive FIT or cologuard Any colorectal cancer syndromes (FAP, HNPCC, SPS) Patient with poor bowel preparation identified during insertion

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: High definition white light endoscopy<br>colonoscopy performed using high definition equipment | Other: High definition white light endoscopy<br>* High definition equipment will be used to perform colonoscopy<br>|
| Active Comparator: Chromoendoscopy<br>indigo carmine is sprayed on the colon mucosa during withdrawal phase | Other: Chromoendoscopy<br>* Indigo carmine will be sprayed during withdrawal phase of colonoscopy<br>|
| Experimental: Narrow band imaging<br>Narrow band imaging is used during withdrawal phase | Device: Narrow band imaging<br>* Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenomas per colonoscopy | total number of adenomas divided by total number of procedures | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | total number of patients with adenomas divided by total number of procedures | during the procedure | 
| Sessile serrated polyps per colonoscopy | total number of sessile serrated polyps divided by total number of procedures | during the procedure | 
| Sessile serrated polyp detection rate | total number of patients with sessile serrated polyps divided by total number of procedures | during the procedure | 
| Withdrawal time | Time from cecal intubation to end of the procedure | during the procedure | 
| Inspection time | Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies | during the procedure |