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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Sessile Serrated Lesion
• Intervention / Treatment: Procedure: WLI Then NBI Withdrawal; Procedure: NBI Then WLI Withdrawal

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoshen Li, MD; Phone Number: 86-021-31161365; Email: li.zhaoshen@hotmail.com
• Study Contact Backup: Name: Yu Bai, MD; Phone Number: 86-021-31161335; Email: baiyu1998@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital, Second Military Medical University
      • Contact: Yu Bai, MD; Phone Number: 86-021-81873241; Email: baiyu1998@hotmail.com
      • Principal Investigator: Zhaoshen Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WLI Then NBI Withdrawal Group; 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; Patients in WLI then NBI withdrawal group will first be carefully inspected by white light imaging(WLI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to narrow band imaging(NBI) for the second withdraw to detect the lesions which found in second time but not the first.
Active Comparator: NBI Then WLI Withdrawal Group; 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; Patients in NBI then WLI withdrawal group will first be carefully inspected by narrow band imaging(NBI), each polyp found should be removed. According to the ESGE guideline of colorectal polypectomy, the lesions which size between 4-9mm should by removed by cold snare. Cold biopsy forceps could be utilized considering the difficulty in resection of flat and diminutive polyps(size ≤ 3mm). Then change to white light imaging(WLI) for the second withdraw to detect the lesions which found in second time but not the first.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The Second Hospital of Hebei Medical University; Air Force Military Medical University, China; The First Affiliated Hospital of Dalian Medical University; Tengzhou Central People's Hospital; Ankang Central Hospital; Huadong Hospital; The Second Affiliated Hospital of Baotou Medical College; Chongqing General Hospital; Yantaishan Hospital; Heilongjiang provincial hospital; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine; Nongken Jiansanjiang People Hospital of Heilongjiang Province; Qilu Hospital, Shandong University; Provincial Hospital Affiliated to Shandong First Medical University; Haikou People's Hospital; The 900th Hospital of Joint Logistics Support Force
• Investigators: Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Publications and helpful links

General Publications

• 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.
• Zhao S, Song Y, Wang S, Wang R, Feng Z, Gong A, Yang X, Pan P, Yao D, Zhang J, Zhu Y, Li T, Bi J, Ren X, Tang X, Li Q, Yu D, Zheng J, Song B, Wang P, Chen W, Shang G, Xu Y, Xu P, Lai Y, Xu H, Yang X, Sheng J, Tao Y, Li X, Zhu Y, Zhang X, Shen H, Ma Y, Wang F, Wu L, Wang X, Li Z, Bai Y. Reduced Adenoma Miss Rate With 9-Minute vs 6-Minute Withdrawal Times for Screening Colonoscopy: A Multicenter Randomized Tandem Trial. Am J Gastroenterol. 2023 May 1;118(5):802-811. doi: 10.14309/ajg.0000000000002055. Epub 2022 Oct 11.
• Li J, Zhang D, Wei Y, Chen K, Wu R, Peng K, Hou X, Li L, Huang C, Wang Y, Xun L, Xu H, Wang J, Chen Z, Shen M, Liu F. Colorectal Sessile Serrated Lesion Detection Using Linked Color Imaging: A Multicenter, Parallel Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):328-336.e2. doi: 10.1016/j.cgh.2022.03.033. Epub 2022 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): March 28, 2024
• Study Completion (Estimated): May 28, 2024

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colonoscopy; Narrow Band Imaging; Sessile Serrated Lesions Miss Rate; Sessile Serrated Lesions Detection Rate
• Other Study ID Numbers: NVWSDR-202212

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No