Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial

Shanghai Jiao Tong University School of Medicine

Status: Enrolling

Conditions: Colorectal Adenoma

Treatments: Device: Enhanced White Light Imaging; Device: White Light lmaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06979232

LY2024-320-C

Details and patient eligibility

About

1. Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);
2. Study Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI) for Detection Rates of Sessile Serrated Lesions (SSLs), Total Polyp Detection Rate, and Advanced Adenoma Detection Rate;
3. Study on Polyp Characteristics (Size, Location, etc.) Observed Using Conventional White Light Endoscopy (WLI) and Enhanced White Light Endoscopy (E-WLI).

Full description

Before colonoscopy, gastroenterology specialists stratified eligible patients according to 1) colorectal cancer screening, 2) positive fecal immunochemical test (FIT) results or gastrointestinal symptoms, and 3) follow-up colonoscopy after colorectal polyp treatment. Patients were then randomized in a 1:1 ratio to receive either colonoscopy with enhanced white light imaging (E-WLI group) or high-definition conventional white light imaging (WLI group) during both insertion and withdrawal phases. Randomization was based on random number lists generated by the coordinating center for each participating site. Endoscopists performing the procedures were not involved in generating the randomization sequence. All procedures were performed by experienced endoscopists at participating centers (>2000 colonoscopy screenings). All procedures utilized endoscopes with "Xiaohua Tanying" technology that incorporated E-WLI functionality. Bowel preparation was assessed and graded by the performing endoscopist using the Boston Bowel Preparation Scale (BBPS). Endoscopy specialists and healthcare facility staff followed standard procedures for patient management and monitoring, including anesthesia. Cecal intubation was verified by the endoscopist through photographic documentation identifying the ileocecal valve and appendiceal orifice. Insertion and withdrawal times were measured through video recording analysis, excluding time spent on therapeutic interventions and washing. Endoscopists were required to maintain a minimum withdrawal inspection time of 6 minutes (with at least 2 minutes each for right colon, transverse colon, and left colon). Regardless of group assignment (E-WLI or WLI), when polyps were detected during the procedure, they were observed using both WLI and E-WLI (2 modes), with images captured in each mode. The location, size, and morphology (Paris classification) of all polyps were documented. All polyps were removed (or biopsied if unresectable), and pathological results were obtained. For hyperplastic polyps in the rectum, if more than 3 diminutive polyps were present, only the first 3 detected polyps required management.

Enrollment: 800 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Male or female aged 45 to 85
• 2. Patients undergoing colonoscopy for colorectal cancer screening, positive fecal immunochemical test (FIT) results, gastrointestinal symptoms, or follow-up examination after colorectal polyp treatment
• 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. Have had drug or alcohol abuse or psychological disorders in the past five years.
• 4. Pregnant or lactating patients;
• 5. Known to have polyposis syndrome;
• 6. Patients with gastrointestinal bleeding;
• 7. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
• 8.Patients with contraindications to tissue biopsy;
• 9. History of allergies to the ingredients in intestinal cleansers;
• 10. 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.
• 11. Researchers believe that patients are not suitable to participate in the trial.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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800 participants in 2 patient groups, including a placebo group

E-WLI

Experimental group

Description:

Enhanced White Light Imaging

Treatment:

Device: Enhanced White Light Imaging

WLI

Placebo Comparator group

Description:

White Light lmaging

Treatment:

Device: White Light lmaging