Clinical trial NCT06979232: Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
Official title: Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Adenoma
Keywords: Enhanced white light endoscopy
Adenoma detection rate
Randomized controlled trial
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-05-18
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: 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).

Detailed 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.

Eligibility criteria: 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.

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: Lanzhou
country: China
facility: The First People's Hospital of Lanzhou City
state: Gansu
city: Harbin
country: China
facility: The Third Affiliated Hospital of Heilongjiang University of Chinese Medicine
state: Heilongjiang
city: Jinan
country: China
facility: Jinan Third People's Hospital
state: Shandong
city: Aksu
country: China
facility: The First People's Hospital of Aksu
state: Xinjiang
city: Korla
country: China
facility: People's Hospital of Bayingolin Mongol Autonomous Prefecture
state: Xinjiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou First People's Hospital
state: Zhejiang
Study officials:
References: