Colorectal AdenomaNCT06979232
Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
A study testing Enhanced White Light Imaging and White Light lmaging in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Colorectal Adenoma
- What is being tested?
- Enhanced White Light Imaging and White Light lmaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 845 participants
- Where
- 7 sitesChina
- Study dates
- 20 Sep 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Chongqing General Hospital
Chongqing, Chongqing Municipality
The Third Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150030
People's Hospital of Bayingolin Mongol Autonomous Prefecture
Korla, Xinjiang, 841000
The First People's Hospital of Lanzhou City
Lanzhou, Gansu, 730050
Armed Police Forces Hospital of Sichuan
Leshan, Sichuan
Ningbo Ninth Hospital
Ningbo, Zhejiang
Taizhou First People's Hospital
Taizhou, Zhejiang, 318020
About this study
- Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);
- 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;
- Study on Polyp Characteristics (Size, Location, etc.) Observed Using Conventional White Light Endoscopy (WLI) and Enhanced White Light Endoscopy (E-WLI).
Read the 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.
- Conditions
- Colorectal Adenoma
- Being tested
- Enhanced White Light Imaging, White Light lmaging
- Keywords
- Enhanced white light endoscopy, Adenoma detection rate, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced White Light ImagingDevice
Use of E-WLI for colon inspection during both insertion and withdrawal phase of colonoscopy
White Light lmagingDevice
Use of WLl for colon inspection during both insertion and withdrawal phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| E-WLI | Experimental | Enhanced White Light Imaging Receives: Device: Enhanced White Light Imaging |
| WLI | Placebo comparator | White Light lmaging Receives: Device: White Light lmaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy
Measured: 14 days
Secondary outcomes (17)
Polyp Detection Rate(PDR)
Calculated by dividing the total number of patients with detected polyps by the total number of patients undergoing colonoscopy.
Measured: 14 days
Sessile serrated lesion detection rate (SDR)
SSLDR was calculated by dividing the total number of patients detected with sessile serrated lesions by the total number of patients who underwent colonoscopy.
Measured: 14 days
Advanced Adenoma Detection Rate (aADR)
Calculated by dividing the total number of patients with detected advanced adenomas by the total number of patients undergoing colonoscopy.
Measured: 14 days
Mean number of polyps per patient (MPP)
Calculated by dividing the total number of detected polyps by the total number of patients undergoing colonoscopy.
Measured: 14 days
Mean number of Adenomas per patient(MAP)
Calculated by dividing the total number of detected adenomas by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Polyps of Different Sizes
lt is calculated by dividing the number of patients with polyps with different sizes by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Adenomas with Different Morphologies
lt is calculated by dividing the number of patients with adenomas of different morphologies by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Adenomas with Different Morphologies
lt is calculated by dividing the number of adenomas with different morphologies by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Polyps of Different Sizes
lt is calculated by dividing the number of polyps with different sizes by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Adenomas of Different Sizes
lt is calculated by dividing the number of adenomas with different sizes by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Adenomas of Different Sizes
lt is calculated by dividing the number of adenomas with different sizes by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Adenomas in Different Locations
lt is calculated by dividing the number of patients with detected adenomas in different locations by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Adenomas in Different Locations
lt is calculated by dividing the number of detected adenomas in different locations by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Polyps in Different Locations
lt is calculated by dividing the number of patients with polyps in different locations by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Polyps in Different Locations
lt is calculated by dividing the number of detected polyps in different locations by the total number of patients undergoing colonoscopy.
Measured: 14 days
Detection Rate of Polyps with Different Morphologies
lt is calculated by dividing the number of patients with polyps of different morphologies by the total number of patients undergoing colonoscopy.
Measured: 14 days
Average Number of Polyps with Different Morphologies
lt is calculated by dividing the number of polyps with different morphologies by the total number of patients undergoing colonoscopy.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start20 Sep 2025
- Primary completion18 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979232
- Sponsor's protocol ID
- LY2024-320-C
- Status last verified
- May 2026
- First submitted
- 11 May 2025
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced White Light Endoscopy Versus Conventional White Light Endoscopy for Colorectal Adenoma Detection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06979232
- Acronym / sponsor ID
- LY2024-320-C
- Conditions
- Colorectal Adenoma
- Keywords
- Enhanced white light endoscopy, Adenoma detection rate, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 845 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study on Adenoma Detection Rate (ADR) Comparing Enhanced White Light Endoscopy (E-WLI) versus Conventional White Light Endoscopy (WLI);
- 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;
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-WLI | Experimental | Device: Enhanced White Light ImagingEnhanced White Light Imaging |
| WLI | Placebo comparator | Device: White Light lmagingWhite Light lmaging |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced White Light ImagingUse of E-WLI for colon inspection during both insertion and withdrawal phase of colonoscopy | Device | E-WLI |
| White Light lmagingUse of WLl for colon inspection during both insertion and withdrawal phase of colonoscopy | Device | WLI |
Primary outcome
Adenoma detection rate (ADR)
Time frame: 14 days
ADR was calculated by dividing the total number of patients detected with adenomas by the total number of patients who underwent colonoscopy
17 secondary outcomes
Polyp Detection Rate(PDR)
Time frame: 14 days
Sessile serrated lesion detection rate (SDR)
Time frame: 14 days
Advanced Adenoma Detection Rate (aADR)
Time frame: 14 days
Mean number of polyps per patient (MPP)
Time frame: 14 days
Mean number of Adenomas per patient(MAP)
Time frame: 14 days
Detection Rate of Polyps of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas with Different Morphologies
Time frame: 14 days
Average Number of Adenomas with Different Morphologies
Time frame: 14 days
Average Number of Polyps of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas of Different Sizes
Time frame: 14 days
Average Number of Adenomas of Different Sizes
Time frame: 14 days
Detection Rate of Adenomas in Different Locations
Time frame: 14 days
Average Number of Adenomas in Different Locations
Time frame: 14 days
Detection Rate of Polyps in Different Locations
Time frame: 14 days
Average Number of Polyps in Different Locations
Time frame: 14 days
Detection Rate of Polyps with Different Morphologies
Time frame: 14 days
Average Number of Polyps with Different Morphologies
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced White Light Imaging and White Light lmaging in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (ADR) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.