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

Not Applicable

Recruiting

• Conditions: Colorectal Sessile Serrated Lesion

• Registration Number: NCT05684328
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-13
• Study Start: 2023-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-03-28
• Study Completion: 2024-05-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
sessile serrated lesions miss rate(SSLMR)	60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
adenoma detection rate(ADR)	60 minutes	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.
adenoma miss rate(AMR)	60 minutes	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.
sessile serrated lesions detection rate(SSLDR)	60 minutes	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.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China