Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT06979232
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: