Clinical trial NCT05684328: Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesion
Official title: Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesions：a Multicenter，Random，Back-to-back Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Sessile Serrated Lesion
Keywords: Sessile Serrated Lesions Miss Rate
Sessile Serrated Lesions Detection Rate
Narrow Band Imaging
Colonoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Dalian Medical University
name: The Second Hospital of Hebei Medical University
name: Yantaishan Hospital
name: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: 900 Hospital of Joint Logistics Support Force of PLA
name: Heilongjiang provincial hospital
name: Ankang Central Hospital
name: Nongken Jiansanjiang People Hospital of Heilongjiang Province
name: Huadong Hospital
name: The Second Affiliated Hospital of Baotou Medical College
name: Qilu Hospital, Shandong University
name: Shandong First Medical University
name: Air Force Military Medical University, China
name: Tengzhou Central People's Hospital
name: Chongqing General Hospital
name: Haikou People's Hospital
First posted: 2023-01-13
Enrollment: 840
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: sessile serrated lesions miss rate(SSLMR)
timeFrame: 60 minutes
Secondary outcomes:
measure: sessile serrated lesions detection rate(SSLDR)
timeFrame: 60 minutes
measure: adenoma miss rate(AMR)
timeFrame: 60 minutes
measure: adenoma detection rate(ADR)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.