Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesion

Study Overview
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Brief Summary
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Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. But no randomized controlled trials with NBI versus white light imaging(WLI) have been conducted to give a definitive conclusion with statistically significant differences. Therefore, we performed a multicenter, prospective, back to back, randomized controlled trial to compare sessile serrated lesions detection and miss rate of withdraw by NBI and WLI in colonoscopy.

Official Title
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Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesions：a Multicenter，Random，Back-to-back Trial

Conditions
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Colorectal Sessile Serrated Lesion

Intervention / Treatment
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* Procedure: WLI Then NBI Withdrawal
* Procedure: NBI Then WLI Withdrawal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients whose age are between 45-85 Patients who have indications for screening Patients who have signed inform consent form. Exclusion Criteria: Patients who have undergone colonic resection Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination Patients with highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy Patients with inflammatory bowel diseases Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis). Patients with pregnancy, severe chronic cardiopulmonary and renal disease. Patients with therapeutic colonoscopy for existing lesions Patients with failed cecal intubation Patients with poor bowel preparation quality that necessitated a second bowel preparation Patients refusing to participate or to provide informed consent

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WLI Then NBI Withdrawal Group<br>After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by white light imaging(WLI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with narrow band imaging(NBI). Stop watch will be utilized to remind endoscopists. | Procedure: WLI Then NBI Withdrawal<br>* Patients in WLI then NBI withdrawal group will first be carefully inspected by white light imaging(WLI), each polyp found should be removed by cold snare. Then change to narrow band imaging(NBI) for the second withdraw to detect the lesions which found in second time but not the first.<br>|
| Active Comparator: NBI Then WLI Withdrawal Group<br>After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by narrow band imaging(NBI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with white light imaging(WLI). Stop watch will be utilized to remind endoscopists. | Procedure: NBI Then WLI Withdrawal<br>* Patients in NBI then WLI withdrawal group will first be carefully inspected by narrow band imaging(NBI), each polyp found should be removed by cold snare. Then change to white light imaging(WLI) for the second withdraw to detect the lesions which found in second time but not the first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sessile serrated lesions miss rate(SSLMR) | Sessile serrated lesions(SSLs) detected in the second-pass examination were defined as missed SSLs; the sessile serrated lesions miss rate(SSLMR) was defined as follows: number of SSLs detected in the second-pass examination/total number of SSLs detected in both two pass. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sessile serrated lesions detection rate(SSLDR) | Sessile serrated lesions detection rate(SSLDR) is the number of patients with at least one sessile serrated lesion detected by narrow band imaging or white light imaging, divided by the total number of patients. | 60 minutes | 
| adenoma miss rate(AMR) | Adenomas detected in the second-pass examination were defined as missed adenomas; the adenoma miss rate(AMR) was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass. | 60 minutes | 
| adenoma detection rate(ADR) | Adenoma detection rate(ADR) is the number of patients with at least one adenoma detected by narrow band imaging or white light imaging, divided by the total number of patients. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sessile Serrated Lesions Miss Rate, Sessile Serrated Lesions Detection Rate, Narrow Band Imaging, Colonoscopy