Colorectal Adenoma
Conditions
Keywords
Spectral Focused Imaging, Colorectal adenoma, ADR
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'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).
Interventions
DEVICESpectral Focused Imaging
Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
DEVICEWhite Light Imaging
Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy
Sponsors
First Affiliated Hospital of Ningbo University
Nanchong Central Hospital
First Affiliated Hospital of Xinjiang Medical University
West China Forth Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
Seventh Medical Center of PLA Army General Hospital
Tongji Hospital
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate (ADR) | 14 days | ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sessile serrated lesion detection rate (SSLDR) | 14 days | SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy |
| Advanced Adenoma Detection Rate | 14 days | Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy. |
| Mean number of polyps per patient | 14 days | Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy. |
| Mean number of Adenomas per patient(MAP) | 14 days | Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy. |
| Detection Rate of Polyps of Different Sizes | 14 days | 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. |
| Detection Rate of Adenomas with Different Morphologies | 14 days | 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. |
| Average Number of Adenomas with Different Morphologies | 14 days | 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. |
| Average Number of Polyps of Different Sizes | 14 days | 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. |
| Detection Rate of Adenomas of Different Sizes | 14 days | 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. |
| Polyp Detection Rate(PDR) | 14 days | Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy. |
| Detection Rate of Adenomas in Different Locations | 14 days | 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. |
| Average Number of Adenomas in Different Locations | 14 days | 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. |
| Detection Rate of Polyps in Different Locations | 14 days | 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. |
| Average Number of Polyps in Different Locations | 14 days | 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. |
| Detection Rate of Polyps with Different Morphologies | 14 days | 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. |
| Average Number of Polyps with Different Morphologies | 14 days | 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. |
| Insertion Time of Colonoscopy | 14 days | The time taken from the rectum to the cecum. |
| Withdrawal Time of Colonoscopy | 14 days | The time taken to complete the examination starting from the cecum. |
| Cecal Intubation Rate | 14 days | It is calculated by dividing the number of colonoscopies that reach the cecum by the total number of colonoscopies performed. |
| Average Number of Adenomas of Different Sizes | 14 days | 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. |
Countries
China
Outcome results
None listed