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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2072

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects aged ≥45 years, regardless of gender;
  2. Subjects undergoing screening colonoscopy;
  3. Subjects with no prior colonoscopy;
  4. Voluntarily provide written informed consent.

Exclusion Criteria:

  1. Subjects unable to cooperate with or tolerate colonoscopy;
  2. Subjects with inflammatory bowel disease;
  3. Known or highly suspected colorectal obstruction;
  4. History of colorectal surgery;
  5. Chronic recurrent constipation;
  6. Failure to discontinue anticoagulants or antiplatelet agents for at least 1 week before the procedure;
  7. Poor bowel preparation with an inadequate Aronchick scale score during colonoscopy;
  8. Failed cecal intubation;
  9. High-risk conditions including severe cardiovascular and cerebrovascular diseases, uncorrected severe anemia or active infection;
  10. Pregnant or breastfeeding women;
  11. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: WLI Then LCI Withdrawal
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.
Procedure: LCI Then WLI Withdrawal
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZhuHai Hospital
Jiangmen Central Hospital
Yangjiang People's Hospital
Longgang District People's Hospital of Shenzhen
The Third People's Hospital of Huizhou
Shunde First People's Hospital of Foshan
Zhongshan Guzhen People's Hospital
Sihui Wanlong Hospital
Suixi People's Hospital of Zhanjiang

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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