Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal energy is further concentrated on the absorption peak wavelength of microvessels by using digital spectral processing techniques. This technology, combined in the latest generation SonoScape\'s endoscopes (SonoScape Co, Shenzhen, China) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with SFI are encouraging but are scanty and limited to back-to back studies. This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI is superior to WLI endoscopy in terms of adenoma detection
45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of colonoscopy. All procedures are performed with a high-definition HD-580 series videocolonscopes with or without magnification (SonoScape Co, Shenzhen, China). The primary outcome measure is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
698
Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy
Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science
Wuhan, Hubei, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
West China School of Public Health West China Fourth Hospital
Chengdu, Sichuan, China
NanChong Center Hospital
Nanchong, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Adenoma detection rate (ADR)
ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy
Time frame: 14 days
Polyp Detection Rate(PDR)
Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Sessile serrated lesion detection rate (SSLDR)
SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy
Time frame: 14 days
Advanced Adenoma Detection Rate
Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Mean number of polyps per patient
Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Mean number of Adenomas per patient(MAP)
Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Polyps of Different Sizes
It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Adenomas with Different Morphologies
It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Adenomas with Different Morphologies
It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Polyps of Different Sizes
It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Adenomas of Different Sizes
It is calculated by dividing the number of patients with large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Adenomas of Different Sizes
It is calculated by dividing the number of large (≥10 mm), small (6-9 mm), and diminutive (≤5 mm) adenomas by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Adenomas in Different Locations
It is calculated by dividing the number of patients with detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Adenomas in Different Locations
It is calculated by dividing the number of detected adenomas in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Polyps in Different Locations
It is calculated by dividing the number of patients with detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Polyps in Different Locations
It is calculated by dividing the number of detected polyps in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, and cecal region by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Detection Rate of Polyps with Different Morphologies
It is calculated by dividing the number of patients with 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Average Number of Polyps with Different Morphologies
It is calculated by dividing the number of 0-Ip, 0-Is, 0-Isp, and 0-IIa polyps by the total number of patients undergoing colonoscopy.
Time frame: 14 days
Insertion Time of Colonoscopy
The time taken from the rectum to the cecum.
Time frame: 14 days
Withdrawal Time of Colonoscopy
The time taken to complete the examination starting from the cecum.
Time frame: 14 days
Cecal Intubation Rate
It is calculated by dividing the number of colonoscopies that reach the cecum by the total number of colonoscopies performed.
Time frame: 14 days
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