Clinical trial NCT06603948: Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection
Official title: Colorectal Adenoma Detection Using Spectral Focused Imaging Versus White Light Imaging: a Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Adenoma
Keywords: Spectral Focused Imaging
Colorectal adenoma
ADR
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Fujian Provincial Hospital
name: First Affiliated Hospital of Ningbo University
name: Nanchong Central Hospital
name: First Affiliated Hospital of Xinjiang Medical University
name: West China Forth Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Seventh Medical Center of PLA Army General Hospital
name: Tongji Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: People's Hospital of Rizhao Lanshan
name: Taicang First People's Hospital
name: Lingshan people's Hospital
name: Songming People's Hospital
name: The People's hospital of wanzai county
name: Xiangning People's Hospital
name: Wuhan Central Hospital
name: Hunan University of Traditional Chinese Medicine
First posted: 2024-09-19
Enrollment: 800
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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\&#39;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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 1. Male or female aged 45 to 85
* 2. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
* 3. Capable of providing informed consent and agreeing to participate
* 4. Able and willing to follow all research processes

Exclusion Criteria:

* 1. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
* 2. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
* 3. Pregnant or lactating patients;
* 4. Known to have polyposis syndrome;
* 5. Patients with gastrointestinal bleeding;
* 6. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
* 7. Patients with contraindications to tissue biopsy;
* 8. History of allergies to the ingredients in intestinal cleansers;
* 9. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
* 10. Researchers believe that patients are not suitable to participate in the trial;
* 11. Have had drug or alcohol abuse or psychological disorders in the past five years.

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: 14 days
Secondary outcomes:
measure: Polyp Detection Rate(PDR)
timeFrame: 14 days
measure: Sessile serrated lesion detection rate (SSLDR)
timeFrame: 14 days
measure: Advanced Adenoma Detection Rate
timeFrame: 14 days
measure: Mean number of polyps per patient
timeFrame: 14 days
measure: Mean number of Adenomas per patient(MAP)
timeFrame: 14 days
measure: Detection Rate of Polyps of Different Sizes
timeFrame: 14 days
measure: Detection Rate of Adenomas with Different Morphologies
timeFrame: 14 days
measure: Average Number of Adenomas with Different Morphologies
timeFrame: 14 days
measure: Average Number of Polyps of Different Sizes
timeFrame: 14 days
measure: Detection Rate of Adenomas of Different Sizes
timeFrame: 14 days
measure: Average Number of Adenomas of Different Sizes
timeFrame: 14 days
measure: Detection Rate of Adenomas in Different Locations
timeFrame: 14 days
measure: Average Number of Adenomas in Different Locations
timeFrame: 14 days
measure: Detection Rate of Polyps in Different Locations
timeFrame: 14 days
measure: Average Number of Polyps in Different Locations
timeFrame: 14 days
measure: Detection Rate of Polyps with Different Morphologies
timeFrame: 14 days
measure: Average Number of Polyps with Different Morphologies
timeFrame: 14 days
measure: Insertion Time of Colonoscopy
timeFrame: 14 days
measure: Withdrawal Time of Colonoscopy
timeFrame: 14 days
measure: Cecal Intubation Rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Nanning
country: China
facility: The People'S Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Qinzhou
country: China
facility: Lingshan County People's Hospital
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science
state: Hubei
city: Yichun
country: China
facility: The First Affiliated Hospital of Yichun University/The people's Hospital of Wanzai County
state: Jiangxi
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Chengdu
country: China
facility: West China School of Public Health West China Fourth Hospital
state: Sichuan
city: Nanchong
country: China
facility: NanChong Center Hospital
state: Sichuan
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: