Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate
July 30, 2026 updated by: Nanfang Hospital, Southern Medical University
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2072
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bitao Lin, MD
- Phone Number: +86 137-2532-1385
- Email: linbitao1996@163.com
Study Contact Backup
- Name: Zelong Han, MD
- Phone Number: +86 20-6278-7385
- Email: hanzelong2025@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Subjects aged ≥45 years, regardless of gender;
- Subjects undergoing screening colonoscopy;
- Subjects with no prior colonoscopy;
- Voluntarily provide written informed consent.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: WLI Then LCI Withdrawal Group
Tandem colonoscopy of the entire colorectum was performed, with initial observation using conventional white-light imaging, followed by linked color imaging.
|
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.
|
|
Active Comparator: LCI Then WLI Withdrawal Group
Tandem colonoscopy of the entire colorectum was performed, with initial observation using linked color imaging, followed by conventional white-light imaging.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adenoma miss rate (AMR)
Time Frame: One day
|
The number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.
|
One day
|
|
advanced adenomas miss rate (AAMR)
Time Frame: One day
|
the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
|
One day
|
|
polyps miss rate (PMR)
Time Frame: One day
|
the number of polyps detected in the second-pass examination/total number of polyps detected in the two pass.
|
One day
|
|
sessile serrated lesions detection rate (SSLDR)
Time Frame: One day
|
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.
|
One day
|
|
adenomas detection rate (ADR)
Time Frame: One day
|
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.
|
One day
|
|
advanced adenomas detection rate (AADR)
Time Frame: One day
|
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.
|
One day
|
|
polyps detection rate (PDR)
Time Frame: One day
|
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.
|
One day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
February 1, 2029
Study Registration Dates
First Submitted
July 30, 2026
First Submitted That Met QC Criteria
July 30, 2026
First Posted (Actual)
August 4, 2026
Study Record Updates
Last Update Posted (Actual)
August 4, 2026
Last Update Submitted That Met QC Criteria
July 30, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- NFEC-2026-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.