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

Naval Military Medical University

Status: Enrolling

Conditions: Colorectal Sessile Serrated Lesion

Treatments: Procedure: NBI Then WLI Withdrawal; Procedure: WLI Then NBI Withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT05684328

NVWSDR-202212

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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840 participants in 2 patient groups

WLI Then NBI Withdrawal Group

Experimental group

Description:

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.

Treatment:

Procedure: WLI Then NBI Withdrawal

NBI Then WLI Withdrawal Group

Active Comparator group

Description:

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.

Treatment:

Procedure: NBI Then WLI Withdrawal