Colorectal Sessile Serrated LesionNCT07745842
Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate
A study testing WLI Then LCI Withdrawal and LCI Then WLI Withdrawal in people with Colorectal Sessile Serrated Lesion, run by Nanfang Hospital, Southern Medical University.
Trial summary
This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Sessile Serrated Lesion
- What is being tested?
- WLI Then LCI Withdrawal and LCI Then WLI Withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,072 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged ≥45 years, regardless of gender;
- Subjects undergoing screening colonoscopy;
- Subjects with no prior colonoscopy;
- Voluntarily provide written informed consent.
Who cannot join
- Subjects unable to cooperate with or tolerate colonoscopy;
- Subjects with inflammatory bowel disease;
- Known or highly suspected colorectal obstruction;
- History of colorectal surgery;
- Chronic recurrent constipation;
- Failure to discontinue anticoagulants or antiplatelet agents for at least 1 week before the procedure;
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- Poor bowel preparation with an inadequate Aronchick scale score during colonoscopy;
- Failed cecal intubation;
- High-risk conditions including severe cardiovascular and cerebrovascular diseases, uncorrected severe anemia or active infection;
- Pregnant or breastfeeding women;
- Subjects deemed ineligible for participation in this trial at the investigator's discretion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).
- Conditions
- Colorectal Sessile Serrated Lesion
- Being tested
- WLI Then LCI Withdrawal, LCI Then WLI Withdrawal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WLI Then LCI WithdrawalProcedure or surgery
Patients in the WLI then LCI withdrawal group first underwent careful endoscopic inspection with white-light imaging (WLI). The endoscopic setting was then switched to linked color imaging (LCI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.
LCI Then WLI WithdrawalProcedure or surgery
Patients in the LCI then WLI withdrawal group first underwent careful endoscopic inspection with linked color imaging (LCI). The endoscopic setting was then switched to white-light imaging (WLI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated.
| Study group | Role | What they receive |
|---|---|---|
| WLI Then LCI Withdrawal Group | Experimental | Tandem colonoscopy of the entire colorectum was performed, with initial observation using conventional white-light imaging, followed by linked color imaging. Receives: Procedure: WLI Then LCI Withdrawal |
| LCI Then WLI Withdrawal Group | Active comparator | Tandem colonoscopy of the entire colorectum was performed, with initial observation using linked color imaging, followed by conventional white-light imaging. Receives: Procedure: LCI Then WLI Withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
sessile serrated lesions miss rate(SSLMR)
The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass.
Measured: One day
Secondary outcomes (7)
adenoma miss rate (AMR)
The number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
Measured: One day
advanced adenomas miss rate (AAMR)
the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
Measured: One day
polyps miss rate (PMR)
the number of polyps detected in the second-pass examination/total number of polyps detected in the two pass.
Measured: One day
sessile serrated lesions detection rate (SSLDR)
the number of patients with at least one sessile serrated lesion detected by linked color imaging or white light imaging, divided by the total number of patients.
Measured: One day
adenomas detection rate (ADR)
the number of patients with at least one adenoma detected by linked color imaging or white light imaging, divided by the total number of patients.
Measured: One day
advanced adenomas detection rate (AADR)
the number of patients with at least one advanced adenoma detected by linked color imaging or white light imaging, divided by the total number of patients.
Measured: One day
polyps detection rate (PDR)
the number of patients with at least one polyp detected by linked color imaging or white light imaging, divided by the total number of patients.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Sessile Serrated LesionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shunde First People's Hospital of Foshan, ZhuHai Hospital, Jiangmen Central Hospital, Yangjiang People's Hospital, Zhongshan Guzhen People's Hospital, Sihui Wanlong Hospital, The Third People's Hospital of Huizhou, Longgang District People's Hospital of Shenzhen, Suixi People's Hospital of Zhanjiang
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745842
- Sponsor's protocol ID
- NFEC-2026-304
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07745842
- Acronym / sponsor ID
- NFEC-2026-304
- Conditions
- Colorectal Sessile Serrated Lesion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,072 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shunde First People's Hospital of Foshan, ZhuHai Hospital, Jiangmen Central Hospital, Yangjiang People's Hospital, Zhongshan Guzhen People's Hospital, Sihui Wanlong Hospital, The Third People's Hospital of Huizhou, Longgang District People's Hospital of Shenzhen, Suixi People's Hospital of Zhanjiang
- Study start
- Aug 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 4 Aug 2026 (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.
This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WLI Then LCI Withdrawal Group | Experimental | Procedure: WLI Then LCI WithdrawalTandem colonoscopy of the entire colorectum was performed, with initial observation using conventional white-light imaging, followed by linked color imaging. |
| LCI Then WLI Withdrawal Group | Active comparator | Procedure: LCI Then WLI WithdrawalTandem colonoscopy of the entire colorectum was performed, with initial observation using linked color imaging, followed by conventional white-light imaging. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged ≥45 years, regardless of gender;
- Subjects undergoing screening colonoscopy;
- Subjects with no prior colonoscopy;
- Voluntarily provide written informed consent.
Key exclusion criteria (11 listed)
- Subjects unable to cooperate with or tolerate colonoscopy;
- Subjects with inflammatory bowel disease;
- Known or highly suspected colorectal obstruction;
- History of colorectal surgery;
- Chronic recurrent constipation;
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 |
|---|---|---|
| WLI Then LCI WithdrawalPatients in the WLI then LCI withdrawal group first underwent careful endoscopic inspection with white-light imaging (WLI). The endoscopic setting was then switched to linked color imaging (LCI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated. | Procedure or surgery | WLI Then LCI Withdrawal Group |
| LCI Then WLI WithdrawalPatients in the LCI then WLI withdrawal group first underwent careful endoscopic inspection with linked color imaging (LCI). The endoscopic setting was then switched to white-light imaging (WLI) for the second withdrawal. All polyps detected during both inspection passes were resected, and the number of lesions missed on the first withdrawal was subsequently calculated. | Procedure or surgery | LCI Then WLI Withdrawal Group |
Primary outcome
sessile serrated lesions miss rate(SSLMR)
Time frame: One day
The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass.
7 secondary outcomes
adenoma miss rate (AMR)
Time frame: One day
advanced adenomas miss rate (AAMR)
Time frame: One day
polyps miss rate (PMR)
Time frame: One day
sessile serrated lesions detection rate (SSLDR)
Time frame: One day
adenomas detection rate (ADR)
Time frame: One day
advanced adenomas detection rate (AADR)
Time frame: One day
polyps detection rate (PDR)
Time frame: One day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing WLI Then LCI Withdrawal and LCI Then WLI Withdrawal in people with Colorectal Sessile Serrated Lesion, run by Nanfang Hospital, Southern Medical University.
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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zelong Han, MD (+86 20-6278-7385, hanzelong2025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sessile serrated lesions miss rate(SSLMR) (time frame: One day). 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 4 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.